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백혈병: 국가별 치료 선택지

이 페이지는 한국어 임상 치료 설명을 새로 쓰지 않습니다. 권위 출처, 진료 전 정리 질문, 임상시험 검색어, 구축 상태를 보여주는 안전한 시작점입니다.

선택지 정리됨혈액암최종 확인 2026.05

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

Acute myeloid leukemia

United States

  • venetoclax (Venclexta) + azacitidine, decitabine, or low-dose cytarabine[1]FDA-approvednewly diagnosed AML in adults aged 75 or older, or with comorbidities precluding intensive induction chemotherapy · Original accelerated approval notice (2018); refresh against current Drugs@FDA labeling before patient-facing reuse.
  • revumenib (Revuforj)[2]FDA-approvedrelapsed or refractory acute leukemia with a KMT2A translocation, including the AML context, in adult and pediatric patients aged 1 year and older

European Union

  • gilteritinib (Xospata)[3]EMA-authorised (central marketing authorisation)relapsed or refractory AML with a FLT3 mutation, adults · Central EU authorisation only; member-state reimbursement not verified.

United Kingdom

Acute lymphoblastic leukemia

United States

European Union

  • tisagenlecleucel (Kymriah)[6]EMA-authorised (central marketing authorisation)relapsed or refractory B-cell ALL in children and young adults up to 25 years of age · Central EU authorisation only; member-state reimbursement not verified.

United Kingdom

  • tisagenlecleucel (Kymriah)[7]NICE-recommended on the NHS (England)relapsed or refractory B-cell ALL in people 25 years and under · Recommended under the commercial arrangement; NHS England context, not a universal UK availability statement.

Chronic myeloid leukemia

United States

European Union

  • asciminib (Scemblix)[10]EMA-authorised (central marketing authorisation)Philadelphia chromosome-positive CML in chronic phase · Central EU authorisation only; member-state reimbursement not verified.

United Kingdom

  • asciminib (Scemblix)[11]NICE-recommended on the NHS (England)CML after two or more tyrosine kinase inhibitors · Recommended under the commercial arrangement; NHS England context, not a universal UK availability statement.

Chronic lymphocytic leukemia

United States

European Union

  • acalabrutinib (Calquence)[14]EMA-authorised (central marketing authorisation)chronic lymphocytic leukemia, adults (untreated and previously treated contexts) · Central EU authorisation only; member-state reimbursement not verified.

United Kingdom

  • venetoclax (Venclexta) + obinutuzumab[15]NICE-recommended on the NHS (England)untreated chronic lymphocytic leukaemia · Recommended under the commercial arrangement; NHS England context, not a universal UK availability statement.

Leukemia

United States

  • Acalabrutinib (Calquence) plus venetoclax (Venclexta)[13]FDA-approvedNot mutation-restricted in the FDA approval notice; Adults with CLL or SLL; FDA approval notice title and contemporaneous manufacturer reporting describe first-line/previously untreated context, but this queue cell preserves FDA notice wording. · This recent FDA approval does not establish payer coverage, local access, or individual suitability. Combination sequencing, infection risk, bleeding/atrial fibrillation considerations, tumor lysis prophylaxis, and stopping rules require clinician review. Confidence/conflicts: High for FDA approval notice; line-of-therapy detail needs label review.
  • BTK inhibitors (acalabrutinib, zanubrutinib, ibrutinib); venetoclax with obinutuzumab or rituximab; bendamustine plus rituximab; fludarabine/cyclophosphamide/rituximab; BTK inhibitor plus venetoclax; R-CHOP only if Richter syndrome suspected; observation/supportive care in appropriate contexts[16]Standard option (per NCI PDQ)TP53/17p, IGHV, prior therapy, and Richter transformation suspicion affect treatment choice; not all options are biomarker-specific; Symptomatic/treated CLL/SLL, relapsed or refractory settings, and suspected Richter transformation context as NCI sections describe. · NCI PDQ is an evidence summary, not a payer rule or personalized recommendation. Treatment may be deferred with observation in some CLL; therapy choice depends on symptoms, stage, TP53/17p status, IGHV, comorbidities, prior therapies, infection risk, and patient goals. Confidence/conflicts: High for NCI broad modality categories; drug-specific labels require regulator checks.
  • Chemotherapy; radiation therapy including total-body irradiation in transplant preparation contexts; chemotherapy with stem cell transplant; targeted therapies including gemtuzumab ozogamicin, midostaurin, quizartinib, revumenib, enasidenib, gilteritinib, and ivosidenib as NCI-listed targeted options; ATRA and arsenic trioxide for APL contexts[17]Standard option (per NCI PDQ)Treatment is based on AML subtype and may include biomarker testing for targeted therapies; Untreated AML induction, AML in remission/postremission, refractory or recurrent AML, and acute promyelocytic leukemia contexts. · NCI PDQ is an evidence summary and explicitly not formal medical advice or a treatment decision rule. AML treatment depends on subtype, genetics, age, fitness, prior therapy, transplant suitability, infection/bleeding risk, and patient preferences. Confidence/conflicts: High for broad NCI modality categories; drug-specific regulatory status requires separate FDA label/approval checks.
  • Chemotherapy; radiation therapy; chemotherapy with stem cell transplant; targeted therapy with dasatinib, imatinib, or nilotinib in Ph-positive contexts; immunotherapy; CNS prophylaxis with intrathecal/systemic chemotherapy with or without brain radiation[8]Standard option (per NCI PDQ)Philadelphia chromosome/BCR-ABL and CD19/CD22 status may affect targeted/immunotherapy choices; NCI page lists targeted therapy with tyrosine kinase inhibitors in remission context; Newly diagnosed adult ALL induction/postremission, remission, recurrent/refractory contexts, and CNS prophylaxis. · NCI PDQ is an evidence summary, not a payer rule or personalized treatment plan. ALL treatment depends on age, lineage, Philadelphia chromosome/BCR-ABL status, measurable residual disease, CNS involvement, prior therapy, and transplant suitability. Confidence/conflicts: High for broad treatment categories; drug-specific regulatory status requires separate source checks.
  • Momelotinib (Ojjaara); pacritinib (Vonjo)[18]FDA accelerated approvalJAK pathway target context; platelet count below 50,000/microliter relevant to pacritinib source; anemia relevant to momelotinib source; no mutation biomarker required in fetched sources; Intermediate or high-risk myelofibrosis with anemia for momelotinib; intermediate or high-risk primary or secondary myelofibrosis with severe thrombocytopenia for pacritinib accelerated approval. · FDA snapshot is a summary and points to prescribing information for full approved conditions. Pacritinib source states accelerated approval and a confirmatory study condition; this finding does not establish comparative superiority, dosing, payer coverage, or individual eligibility. Confidence/conflicts: High for FDA momelotinib and pacritinib status; no conflict identified.
  • PET-CT directed evaluation and biopsy-directed pathology workup[16]NCI PDQ: standard optionPossible transformation to diffuse large B-cell lymphoma (DLBCL); clonal relationship, TP53/NOTCH1/CDKN2A/B/complex karyotype may affect prognosis per source; Diagnostic evaluation when clinical features raise concern for Richter transformation. · This is a diagnostic/evaluation pathway, not a treatment recommendation or proof that transformation is present. Histologic confirmation and specialist interpretation are required. Confidence/conflicts: High for NCI PDQ diagnostic-context statement; no conflict identified.
  • Quizartinib (Vanflyta) with standard cytarabine and anthracycline induction, cytarabine consolidation, and maintenance monotherapy after consolidation chemotherapy[19]FDA-approvedFLT3 internal tandem duplication (ITD)-positive by FDA-approved test; Newly diagnosed adult FLT3-ITD-positive AML; induction, consolidation, and post-consolidation maintenance setting. · FDA notes quizartinib is not indicated as maintenance monotherapy after allogeneic HSCT and that OS improvement has not been demonstrated in that setting. FDA also notes a boxed warning and REMS for QT prolongation/torsades/cardiac arrest risk; this record does not provide dosing advice. Confidence/conflicts: High for FDA approval scope and REMS caveat.
  • Supportive care including transfusions; erythropoiesis-stimulating agents as source-discussed context; lenalidomide; immunosuppressive therapy; DNA methyltransferase inhibitors including azacitidine/decitabine class; AML induction-type chemotherapy; allogeneic hematopoietic stem cell transplant; imetelstat (Rytelo)[20]FDA-approveddel(5q) relevant to lenalidomide option; lower-risk transfusion-dependent anemia and ESA response status relevant to imetelstat; no single biomarker across all options; MDS treatment based on predicted survival and clinically significant cytopenias; FDA-specific imetelstat lower-risk transfusion-dependent anemia after ESA nonresponse/loss/ineligibility. · PDQ notes the impact of most MDS therapies on survival remains unproven and does not establish payer coverage or individual eligibility. FDA source supports only the imetelstat indication stated; it does not establish use in higher-risk MDS or non-transfusion-dependent anemia. Confidence/conflicts: High for PDQ option classes and FDA imetelstat indication; no conflict identified.
  • Tyrosine kinase inhibitors including asciminib, imatinib, dasatinib, nilotinib, bosutinib, and ponatinib; high-dose therapy with allogeneic bone marrow/stem cell transplantation; hydroxyurea; splenectomy in selected symptom contexts[12]Standard option (per NCI PDQ)Philadelphia chromosome / BCR-ABL1; resistance mutations affect TKI choice; Chronic-phase CML and selected transplant/high-risk contexts; treatment-free remission and discontinuation are discussed as monitored contexts in NCI PDQ. · NCI PDQ is an evidence summary, not a payer rule or individualized treatment plan. TKI choice depends on phase, BCR-ABL1 transcript response, mutation profile, comorbidities, prior intolerance/resistance, pregnancy considerations, and transplant suitability. Confidence/conflicts: High for broad treatment backbone; drug-specific label status requires separate regulator checks.
  • Venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine[1]FDA accelerated approvalNot mutation-restricted in the FDA venetoclax approval notice; Newly diagnosed AML in adults age 75 or older or with comorbidities precluding intensive induction chemotherapy. · FDA's 2018 notice describes accelerated approval based on open-label nonrandomized trials and states continued approval could depend on confirmatory trials; current label status, regimen selection, cytopenia/infection monitoring, and individual suitability require clinician review. Confidence/conflicts: High for FDA approval notice; current label refresh remains an active gap.
  • Watchful waiting; cladribine with or without rituximab; BRAF inhibitors such as vemurafenib, dabrafenib, or encorafenib with or without rituximab or obinutuzumab; rituximab; pentostatin; ibrutinib; re-treatment with cladribine or pentostatin; bendamustine with rituximab; splenectomy; interferon[21]FDA-approvedBRAF V600E is described by NCI PDQ as a classic HCL-defining feature that can aid diagnosis; HCL variant lacks BRAF variants in the NCI PDQ description; Observation for asymptomatic/noncritical cytopenia; treatment when disease progression signs such as symptomatic cytopenias, increasing splenomegaly, or complications are present; moxetumomab historical setting after at least two standard lines. · NCI PDQ is an evidence summary, not a personalized treatment recommendation. NCI explicitly notes FDA has not approved oral vemurafenib for HCL. Moxetumomab's historical approval does not mean current U.S. market availability after discontinuation. Confidence/conflicts: High for NCI evidence-summary and discontinuation update; no current U.S. availability claim made for discontinued Lumoxiti. Moxetumomab pasudotox (Lumoxiti) was discontinued from the US market in 2023 (and its EU marketing authorisation was withdrawn 23 Jul 2021); it is no longer a current option and is omitted here. The remaining options in this entry are genuine FDA-approved/standard hairy-cell-leukemia treatments.
  • aggressive combination chemoimmunotherapy such as R-CHOP or Pola-R-CHP, often followed by autologous or allogeneic stem cell transplant in selected responders[16]NCI PDQ: standard optionDLBCL-type Richter transformation; clonal relationship to CLL affects prognosis per NCI PDQ; DLBCL-type Richter transformation treatment framework after histologic confirmation and response assessment. · NCI PDQ notes prognosis is poor for most patients with DLBCL-type Richter transformation after prior CLL therapy and states there is no standard therapeutic approach for poor-prognosis patients. This entry does not imply transplant eligibility or regimen superiority. Confidence/conflicts: High for NCI PDQ framework; no conflict identified.
  • bosutinib (Bosulif)[22]FDA-approvedPh+ / BCR::ABL1-positive CML; newly diagnosed or resistant/intolerant to prior therapy; Pediatric CP Ph+ CML, newly diagnosed or resistant/intolerant to prior therapy. · FDA approval does not establish individual eligibility, payer coverage, or best sequencing versus other pediatric TKIs. This entry does not provide dosing instructions. Confidence/conflicts: High for U.S. pediatric bosutinib approval scope; no conflict identified.
  • imatinib (Gleevec), dasatinib (Sprycel), nilotinib (Tasigna), bosutinib (Bosulif), allogeneic hematopoietic stem cell transplant[23]FDA-approvedBCR::ABL1-positive / Philadelphia chromosome-positive CML; T315I mutation affects TKI selection; Pediatric CML initial TKI therapy; recurrent/refractory childhood CML alternative TKI or allogeneic HSCT context. · NCI PDQ is a clinician information summary and explicitly is not a formal guideline or individualized recommendation. It does not verify payer coverage or center-specific pediatric transplant eligibility. Confidence/conflicts: High for U.S. NCI PDQ pediatric treatment framework; no conflict identified.
  • imetelstat (Rytelo)[20]FDA-approvednon-del(5q) not required in the U.S. approval notice; low- to intermediate-1 risk disease; prior erythropoiesis-stimulating agent failure/loss of response/ineligibility; Adult low- to intermediate-1-risk MDS with transfusion-dependent anemia after ESA failure/loss of response or ESA ineligibility. · This is a U.S. regulator approval notice and does not establish payer coverage, center-level stocking, or suitability for an individual patient. The FDA notice cites IMerge trial eligibility and efficacy outcomes but does not replace the full label for monitoring and dose-modification details. Confidence/conflicts: High for U.S. approval date, indication scope, and transfusion-threshold wording. No conflict identified.
  • imetelstat (Rytelo)[24]Approvedlow- to intermediate-1 risk MDS; transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks; prior ESA failure/loss of response/ineligibility; U.S. label-management context for adults receiving imetelstat for transfusion-dependent lower-risk MDS. · This is drug-label management information, not a separate efficacy claim. It should not be used as patient-specific dosing advice outside the treating team's supervision. Additional label sections govern dose delays, reductions, liver-test monitoring, infusion-reaction premedication, and cytopenia handling. Confidence/conflicts: High for current U.S. label dosing, monitoring, and discontinuation instructions. No conflict identified.
  • lisocabtagene maraleucel (Breyanzi, liso-cel)[25]FDA accelerated approvalCD19-directed cellular therapy context; prior BTK inhibitor and BCL-2 inhibitor exposure required by FDA indication; Adult relapsed/refractory CLL/SLL after at least two prior therapy lines including a BTK inhibitor and a BCL-2 inhibitor. · Accelerated approval may depend on confirmatory clinical benefit. CAR-T access requires an authorized center, leukapheresis/manufacturing feasibility, bridging/supportive care, and payer review. Confidence/conflicts: High for U.S. FDA indication; no conflict identified.
  • pirtobrutinib (Jaypirca)[26]FDA accelerated approvalPrior covalent BTK inhibitor exposure; FDA notes prior non-covalent BTK inhibitor exclusion from BRUIN-CLL-321; Adult relapsed/refractory CLL/SLL after prior covalent BTK inhibitor. · FDA approval does not establish individual sequencing, payer coverage, or appropriateness after a non-covalent BTK inhibitor. The FDA page lists infection, hemorrhage, cytopenia, cardiac arrhythmia, secondary malignancy, hepatotoxicity, and embryo-fetal toxicity warnings. Confidence/conflicts: High for current U.S. approval scope. No conflict identified.

European Union

  • Acalabrutinib (Calquence); venetoclax (Venclyxto); pirtobrutinib (Jaypirca); ibrutinib (Imbruvica) plus venetoclax; other EMA-authorised CLL combinations depending on product[14]EMA authorisedPrior BTK inhibitor exposure for pirtobrutinib; not otherwise mutation-restricted in broad EMA pages; Untreated and previously treated CLL for acalabrutinib-based regimens; relapsed/refractory CLL after prior BTK inhibitor for pirtobrutinib; Venclyxto combinations by EU label. · EMA central authorisation does not establish member-state reimbursement or access in Germany, France, or other countries. Product-specific labels and national formularies should be checked before patient-facing reuse. Confidence/conflicts: Medium-high; EMA pages are high-confidence for products, but expanded combination details should be checked against final product information.
  • Asciminib (Scemblix) and other EMA-authorised CML TKIs such as imatinib (Glivec), dasatinib (Sprycel), nilotinib (Tasigna), bosutinib (Bosulif), and ponatinib (Iclusig)[10]EMA authorisedPhiladelphia chromosome/BCR-ABL1 context; T315I and prior TKI history may affect product-specific use; CML chronic phase, with product-specific indications depending on prior treatment, resistance/intolerance, and mutation status. · EMA central authorisation does not establish access or reimbursement in Germany, France, or other member states. Product-specific EPARs and mutation/line restrictions should be checked for each TKI before patient-facing reuse. Confidence/conflicts: Medium-high for Scemblix EU authorisation; full multi-TKI EU label details remain active gaps. EU central authorisation only; member-state reimbursement not verified
  • Blinatumomab (Blincyto)[27]EMA authorisedCD19-positive; Philadelphia chromosome status affects adult indications in EMA source; Adult relapsed/refractory CD19-positive B-cell precursor ALL; adult MRD-positive remission; pediatric relapsed/refractory Ph-negative CD19-positive B-cell precursor ALL after specified prior therapies or allo-HSCT. · EMA central authorisation does not establish member-state reimbursement or local availability. Ph status, MRD threshold, prior TKI exposure, prior transplant, and pediatric/adult criteria differ. Confidence/conflicts: High for EMA central-authorisation indication text; no conflict found in fetched source.
  • Imetelstat (Rytelo); luspatercept (Reblozyl)[28]EMA authorisednon-del(5q) status required for EMA Rytelo indication; very low, low, or intermediate-risk MDS and transfusion-dependent anemia relevant to Reblozyl; no mutation biomarker stated; Lower-risk or very-low-to-intermediate-risk transfusion-dependent anemia due to MDS; Rytelo after erythropoietin insufficient response or ineligibility and non-del(5q) status; Reblozyl transfusion-dependent anemia due to very low, low, and intermediate-risk MDS. · EMA central authorisation does not establish Germany, France, or other member-state reimbursement, local access, or individual eligibility. Rytelo and Reblozyl are anemia/MDS-risk specific, not general higher-risk MDS therapy claims. Confidence/conflicts: High for EMA indications; no conflict identified.
  • Kymriah (tisagenlecleucel); Tecartus (brexucabtagene autoleucel)[29]EMA authorisedB-cell ALL; age and relapse criteria for Kymriah; B-cell precursor ALL age 26+ for Tecartus; Germany/France CAR-T access-research map for R/R B-cell ALL. · G-BA English versions are not legally binding, and HAS CAV does not equal individual access. Germany/France center capacity, national coding/funding, and individual eligibility remain open checks. Confidence/conflicts: Medium-high for Germany/France HTA access map; detailed reimbursement and center logistics remain gaps. No conflict identified.
  • Kymriah (tisagenlecleucel); Tecartus (brexucabtagene autoleucel); Besponsa (inotuzumab ozogamicin)[6]EMA authorisedB-cell ALL, B-cell precursor ALL, CD22-positive ALL; age thresholds <=25 for Kymriah and >=26 for Tecartus; Ph-positive prior-TKI caveat for Besponsa; EU relapsed/refractory B-cell ALL option mapping by age, CD19/CD22 biology, relapse history, and treatment-center access. · This is not sequencing advice. Germany, France, and other member states can differ in reimbursement, referral pathways, and qualified CAR-T center availability. Confidence/conflicts: High for EU central authorization map; national reimbursement remains a separate gap. No conflict identified.
  • Moxetumomab pasudotox (Lumoxiti)[30]EMA authorisation withdrawn (23 Jul 2021)No biomarker restriction stated in fetched EMA indication text; Former EU indication: adult relapsed or refractory HCL after at least two prior systemic therapies including a purine nucleoside analogue. · This is a negative/availability cell: the EMA source documents prior authorization and withdrawal, not current EU availability. Member-state or compassionate-access routes are not established by this source. Confidence/conflicts: High for EMA withdrawal/former-indication status; no current availability claim made. EU marketing authorisation WITHDRAWN on 23 July 2021 at AstraZeneca's request following a commercial decision to discontinue marketing; the product was never actually marketed in the EU and is NOT a currently available treatment option. Listed for historical/context completeness only. (Also discontinued from the US market in 2023.)
  • Rituximab (MabThera) in combination with chemotherapy[31]EMA authorisedCD20-positive disease required in EMA MabThera indication; no mutation biomarker stated; Previously untreated advanced-stage CD20-positive pediatric Burkitt lymphoma/Burkitt leukemia/Burkitt-like lymphoma in patients aged 6 months to under 18 years. · EMA central authorisation does not establish member-state reimbursement or local protocol access in Germany, France, or another EU country. This finding is pediatric and CD20-positive/advanced-stage specific; it does not establish an EMA adult Burkitt lymphoma indication from the fetched source. Confidence/conflicts: High for EMA pediatric indication; adult EU Burkitt lymphoma drug/regimen status remains a gap.
  • Ruxolitinib (Jakavi); fedratinib (Inrebic); momelotinib (Omjjara)[32]EMA authorisedJAK inhibitor-naive or prior ruxolitinib treatment status relevant for fedratinib and momelotinib; moderate-to-severe anemia relevant for momelotinib; no mutation biomarker stated; Adult disease-related splenomegaly or symptoms in primary, post-PV, or post-ET myelofibrosis; product-specific JAK inhibitor-naive/prior-ruxolitinib and anemia constraints as stated. · EMA central authorisation does not establish Germany, France, or other member-state reimbursement, local access, or individual eligibility. Omjjara has additional monitoring and orphan designation in the fetched EMA page. Confidence/conflicts: High for EMA indications; no conflict identified.
  • Venetoclax (Venclyxto); quizartinib (Vanflyta); gilteritinib (Xospata); ivosidenib (Tibsovo); gemtuzumab ozogamicin (Mylotarg); glasdegib (Daurismo)[33]EMA authorisedFLT3-ITD for quizartinib; FLT3 mutation for gilteritinib; IDH1 R132 mutation for ivosidenib; CD33-positive for gemtuzumab ozogamicin; not mutation-restricted for venetoclax/glasdegib in their AML contexts; Product-specific EU central indications as stated above: newly diagnosed unfit AML, newly diagnosed FLT3-ITD AML, relapsed/refractory FLT3-mutated AML, newly diagnosed IDH1 R132-mutated AML, newly diagnosed de novo CD33-positive AML except APL. · EMA central authorisation does not establish reimbursement or routine availability in individual EU member states such as Germany or France. Product-specific mutation testing, age, induction-fitness, APL exclusion, combination chemotherapy, and label restrictions apply. Confidence/conflicts: High for EU central-authorisation indications; no conflict found across fetched EMA sources.
  • acalabrutinib (Calquence) plus venetoclax, with or without obinutuzumab[34]ApprovedAdult previously untreated CLL in acalabrutinib-venetoclax combination contexts. · IQWiG/G-BA benefit assessment is not a personalized recommendation and does not mean the regimen is unavailable. The final G-BA documents and German reimbursement conditions should be checked directly. Confidence/conflicts: High for IQWiG/G-BA project status; exact final German reimbursement wording requires the G-BA decision documents. No conflict identified.
  • allogeneic hematopoietic stem cell transplantation (allo-HSCT)[35]HAS reimbursement opinionPh+ / BCR::ABL1-positive CML; T315I or multi-TKI failure may affect sequencing; CML-CP after failure/suboptimal response to two or more TKIs, T315I/high conversion-risk contexts, or advanced-phase development during TKI treatment. · The HAS statement is a care-pathway context note, not a transplant-center eligibility rule. Transplant feasibility depends on specialist assessment, donor availability, disease phase, comorbidities, and local center criteria. Confidence/conflicts: Medium-high for pathway context; specific transplant eligibility remains center-specific. No conflict identified.
  • asciminib (Scemblix)[36]ApprovedPhiladelphia chromosome-positive / BCR::ABL1-positive CML-CP; Adult Ph+ CML-CP after two or more prior TKIs. · G-BA English documents are courtesy translations and not legally binding; the German version and local statutory insurance implementation govern use. The G-BA document notes treatment should be initiated and monitored by specialists experienced in CML. Confidence/conflicts: High for Germany G-BA asciminib HTA scope; no conflict identified. Legal-language caveat applies.
  • asciminib (Scemblix)[35]ApprovedPh+ / BCR::ABL1-positive CML-CP; HAS page states patients with T315I mutation are outside the marketing-authorization scope for this specific asciminib indication; Adult Ph+ CML-CP after two or more prior TKIs; third-line or later treatment in the HAS role statement. · HAS notes the no-T315I scope for this indication and states that comparative positioning versus ponatinib cannot be determined from available comparative data. Local prescribing, reimbursement, and center access should be verified. Confidence/conflicts: High for France HAS reimbursement scope; no conflict identified.
  • blinatumomab (Blincyto)[37]ApprovedCD19-positive; Philadelphia chromosome-negative; adult newly diagnosed consolidation setting; Adult newly diagnosed Ph-negative CD19-positive B-cell precursor ALL, consolidation therapy. · G-BA English PDF is a courtesy translation and only the German version is legally binding. The HTA conclusion does not by itself define individual eligibility, hospital scheduling, or reimbursement coding. Confidence/conflicts: High for G-BA HTA signal; access logistics remain separate. No conflict identified.
  • blinatumomab (Blincyto)[38]ApprovedCD19-positive; Philadelphia chromosome-negative; high-risk first relapse; pediatric age groups; Pediatric high-risk first relapsed Ph-negative CD19-positive B-precursor ALL consolidation therapy; includes German HTA records for age 1 year or older and for infants 1 month to under 1 year. · G-BA English PDFs are courtesy translations; German legal text controls. The infant resolution records orphan-drug additional benefit considered proven by authorization, but detailed extent may require the full German record and local center review. Confidence/conflicts: High for G-BA pediatric blinatumomab HTA signals. No conflict identified.
  • blinatumomab (Blincyto)[39]HAS reimbursement opinionPh-negative; CD19-positive; MRD-negative first complete remission as stated by HAS; Adult Ph-negative CD19-positive B-cell precursor ALL, first complete remission with negative MRD, consolidation therapy. · HAS reimbursement/clinical-benefit assessment does not establish individual eligibility, sequencing, hospital access, or final local contracting details. Confidence/conflicts: High for HAS favorable reimbursement opinion and CAV III signal. No conflict identified.
  • bosutinib (Bosulif)[40]EMA authorisedPh+ / BCR::ABL1-positive CML; EU pediatric CP Ph+ CML age 6 years and older, newly diagnosed or after one or more prior TKIs when listed alternatives are not suitable. · EMA authorization is EU-wide, but national reimbursement and implementation differ; Germany/France payer details for pediatric bosutinib were not separately verified here. Confidence/conflicts: High for EU EMA authorization scope; national access confidence varies by country. No conflict identified.
  • brexucabtagene autoleucel (Tecartus)[41]EMA authorisedB-cell precursor ALL; adult age 26 years and above; Adult R/R B-cell precursor ALL in the EU, age 26 years and above. · EMA authorization does not establish country-specific reimbursement or center availability. The qualified-treatment-center requirement is a key access caveat. Confidence/conflicts: High for EMA-authorized Tecartus ALL indication. No conflict identified.
  • brexucabtagene autoleucel (Tecartus)[42]G-BA benefit assessmentAdult age 26 years and older; B-cell precursor ALL; Germany G-BA post-authorization evidence/benefit-assessment process for Tecartus in adults 26 years and older with R/R B-cell precursor ALL. · This is not a full reimbursement or access rule and not a treatment recommendation. German-language legally binding documents should be checked. Confidence/conflicts: High for G-BA process signal; medium for access implications because this is not a direct funding rule. No conflict identified.
  • imetelstat (Rytelo)[28]EMA authorisednon-del(5q) cytogenetic abnormality required; erythropoietin inadequate or patient cannot be treated with erythropoietin; Adult transfusion-dependent anemia due to very low-, low-, or intermediate-risk non-del(5q) MDS after inadequate erythropoietin effect or erythropoietin ineligibility. · This is an EMA central-authorisation page and does not establish member-state reimbursement, hospital formulary uptake, or country-specific HTA outcomes. EMA also notes blood-count and liver-function monitoring plus treatment stop if transfusion need is not reduced after 24 weeks. Confidence/conflicts: High for EU authorisation status and indication scope from the EPAR. No conflict identified.
  • inotuzumab ozogamicin (Besponsa)[43]EMA authorisedCD22-positive B-cell precursor ALL; Philadelphia chromosome-positive patients should have failed at least one TKI in the adult indication context; pediatric age at least 1 year in updated product information; Adult R/R CD22-positive B-cell precursor ALL; pediatric R/R CD22-positive B-cell precursor ALL age 1 year and older per updated EU product information. · Adult Ph-positive patients have a prior-TKI caveat. Pediatric indication detail should be checked against the current full EMA product information and national reimbursement rules. Confidence/conflicts: High for EMA adult Besponsa indication; medium-high for pediatric update because it was captured from product-information text and should be checked in full label during integration. No conflict identified.
  • inotuzumab ozogamicin (Besponsa)[44]HAS reimbursement opinionCD22-positive; Philadelphia chromosome-negative reimbursement scope in HAS reassessment; Adult relapsed/refractory Ph-negative CD22-positive B-cell precursor ALL in France. · HAS restricts the reimbursement conclusion to the Ph-negative CD22-positive adult population; do not infer public funding for Ph-positive disease or pediatric use from this source. Sequencing versus Blincyto or Kymriah is explicitly not specified by HAS. Confidence/conflicts: High for HAS reimbursement/benefit statement; no conflict identified.
  • luspatercept (Reblozyl)[45]G-BA benefit assessmentESA-naive or no prior ESA-based therapy; without ring-sideroblast restriction in the 2024 German resolution scope; Adult transfusion-dependent anemia due to very low-, low-, or intermediate-risk MDS in ESA-naive/ESA-eligible or non-ring-sideroblast post/ineligible ESA contexts. · G-BA courtesy translation notes only the German version is legally binding. This is German HTA/benefit-assessment context, not bedside eligibility or prescription advice. Exact reimbursement implementation and statutory-insurance use require current German documents. Confidence/conflicts: High for German G-BA assessed indication scopes; German original controls. No conflict identified.
  • luspatercept (Reblozyl)[46]EMA authorisedring sideroblasts; unsatisfactory response to or ineligibility for erythropoietin-based therapy; Adult lower-risk MDS with ring sideroblasts, transfusion-dependent anemia, after unsatisfactory ESA response or ESA ineligibility. · This is a German HTA resolution, not a claim that luspatercept is clinically inappropriate. It records G-BA's additional-benefit conclusion for the comparator and indication scope. German original controls the legal interpretation. Confidence/conflicts: High for G-BA HTA language; no direct conflict, but 2024 expanded-scope resolution should be considered alongside this older ring-sideroblast-specific resolution.
  • luspatercept (Reblozyl)[47]Approvedring sideroblasts; 5q deletion status materially changes French reimbursement opinion; Adult lower-risk MDS with ring sideroblasts and transfusion-dependent anemia after ESA unsatisfactory response or ESA ineligibility; French reimbursement differs by 5q deletion status. · The HAS source is an HTA/reimbursement opinion, not an EMA marketing authorization or individual eligibility rule. Current updates should be checked because this page is older and France may reassess indications. Confidence/conflicts: High for HAS reimbursement distinction as fetched; stale-current-refresh-needed due to age. No conflict identified.
  • pirtobrutinib (Jaypirca)[48]EMA authorisedPrior BTK inhibitor exposure; Adult relapsed/refractory CLL after previous BTK inhibitor treatment. · EU authorization does not equal automatic reimbursement in each member state. Germany/France HTA and country-specific reimbursement remain separate cells. Confidence/conflicts: High for EMA indication scope; national access remains a gap. No conflict identified.
  • pirtobrutinib (Jaypirca)[49]ApprovedPrior BTK inhibitor with or without prior BCL-2 inhibitor; IQWiG separates both subgroups; Adult relapsed/refractory CLL after prior BTK inhibitor, with subgroups by BCL-2 inhibitor exposure. · IQWiG dossier assessment is not the final G-BA benefit decision. Reimbursement and prescribing in Germany should be checked against the final G-BA resolution and German label. Confidence/conflicts: High for IQWiG result; final G-BA decision remains a follow-up. No conflict identified.
  • ponatinib (Iclusig)[50]ApprovedT315I mutation or resistance/intolerance contexts as defined in EU/French source; Philadelphia chromosome-positive disease implied by CML indication context; Adult CML in chronic, accelerated, or blast phase in resistance/intolerance or T315I contexts; HAS also frames T315I as a first-intention context and non-T315I use as a later recourse context. · HAS distinguishes different clinical-added-value levels by T315I status and does not establish individual suitability. EU product information includes cardiovascular and hematologic precautions that require specialist review; no dosing guidance is recorded here. Confidence/conflicts: High for France/EU ponatinib indication scope; no conflict identified.
  • rituximab (MabThera) in combination with chemotherapy[51]ApprovedCD20-positive; First-line pediatric advanced-stage CD20-positive mature B-cell NHL/Burkitt spectrum, age 6 months to under 18 years. · French HAS document endpoint did not expose extractable PDF text in this pass, but the fetched HAS document/search metadata states the pediatric Burkitt-scope opinion. French-language source requires human review before patient-facing reuse. Adult Burkitt reimbursement and hospital protocol details remain separate gaps. Confidence/conflicts: Medium for France HAS pediatric reimbursement scope because the HAS endpoint was fetched but full PDF text was not extractable in this pass; no conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • tisagenlecleucel (Kymriah)[52]ApprovedB-cell ALL; children, adolescents, and young adults up to and including 25 years; Germany G-BA benefit-assessment context for Kymriah in pediatric/young adult R/R B-cell ALL. · G-BA English documents are courtesy translations; only German versions are legally binding. This entry does not establish center capacity, individual reimbursement processing, or hospital access. Confidence/conflicts: High for German G-BA assessment signal; legal review should use German source. No conflict identified.
  • tisagenlecleucel (Kymriah)[29]HAS reimbursement opinionPediatric and young adult B-cell ALL; refractory, post-transplant relapse, or second/later relapse context; France HAS transparency/clinical added-value context for Kymriah in pediatric/young adult R/R B-cell ALL. · HAS clinical added value does not by itself describe hospital scheduling, CAR-T center capacity, or individual eligibility. French reimbursement and center access require local verification. Confidence/conflicts: High for HAS CAV III signal for Kymriah ALL. No conflict identified.

United Kingdom

  • Asciminib (Scemblix)[53]NICE recommendedBCR-ABL1 CML; mutation/resistance status affects TKI choice; CML after two or more prior TKIs. · NICE TA813 is England context and detailed criteria/commercial arrangements should be checked. Devolved nations may differ. This cell does not establish first-line asciminib access in the UK. Confidence/conflicts: High for NICE England-context asciminib after >=2 TKIs; current first-line UK status remains active gap.
  • Azacitidine (Vidaza); lenalidomide (Revlimid); luspatercept in awaiting-development appraisal context[54]EMA authorisedIsolated deletion 5q cytogenetic abnormality required for NICE TA322 lenalidomide cell; IPSS intermediate-2 or high-risk MDS required for NICE TA218 azacitidine cell; Azacitidine for adult higher-risk MDS not eligible for HSCT; lenalidomide for transfusion-dependent anemia in low/intermediate-1 risk del(5q) MDS when other options are insufficient/inadequate; luspatercept not yet recommended in the fetched NICE project page. · NICE applies to England unless otherwise stated and does not establish Scotland, Wales, or Northern Ireland access. Luspatercept is in awaiting-development status in the fetched NICE source and should not be recorded as a NICE-recommended option from that source. Confidence/conflicts: High for NICE azacitidine and lenalidomide recommendations; luspatercept marked in-development only.
  • Cladribine (Litak) with or without rituximab[55]EMA authorisedNo mutation biomarker required by fetched NHS protocol; BSH guideline page covers HCL and HCL variant but the accessible page text is not treatment-detail rich; Newly diagnosed or relapsed/refractory HCL, including HCL-V, per Oxford NSSG protocol. · Oxford NSSG is a regional NHS protocol and does not establish all-UK access or devolved-nation policy. The protocol includes local governance, MDT, and funding caveats; exact dosing is intentionally not captured here. Confidence/conflicts: Medium-high for England protocol status; BSH landing page verifies guideline existence but detailed recommendations are not fully accessible in fetched page.
  • Kymriah (tisagenlecleucel); Tecartus (brexucabtagene autoleucel); Besponsa (inotuzumab ozogamicin)[7]NICE recommendedB-cell ALL; B-cell precursor ALL; CD22-positive disease; age 25-and-under versus 26-and-over thresholds; UK/England relapsed/refractory B-cell ALL advanced-therapy planning by age, CD22 status, and CAR-T service route. · This map does not provide treatment sequencing. Scotland, Wales, and Northern Ireland may use different implementation routes; Wales may point back to NICE for appraised medicines. Confidence/conflicts: High for NICE England advanced ALL access map. No conflict identified.
  • Ruxolitinib (Jakavi); momelotinib (Omjjara); fedratinib (Inrebic); best available therapy context including hydroxycarbamide, other chemotherapies, androgens, splenectomy, radiation therapy, erythropoietin, and red blood cell transfusions as discussed in NICE TA1018 rationale[56]NICE recommendedIntermediate-2 or high-risk disease required in NICE recommendations; moderate-to-severe anemia required for NICE momelotinib recommendation; no mutation biomarker stated; Intermediate-2 or high-risk myelofibrosis with disease-related splenomegaly or symptoms; momelotinib-specific moderate-to-severe anemia and JAK inhibitor-naive or prior-ruxolitinib context; fedratinib after ruxolitinib when momelotinib is unsuitable. · NICE guidance applies to England unless otherwise stated and does not establish Scotland, Wales, or Northern Ireland access. Commercial arrangements and NHS commissioning criteria apply. NICE TA1018 notes its fedratinib recommendation does not include everyone licensed for fedratinib. Confidence/conflicts: High for NICE England-context recommendations; no conflict identified.
  • Venetoclax (Venclyxto) plus obinutuzumab (Gazyvaro); acalabrutinib (Calquence); ibrutinib (Imbruvica) plus venetoclax (Venclyxto); zanubrutinib (Brukinsa)[57]Approved17p deletion or TP53 mutation affects NICE restrictions for acalabrutinib and zanubrutinib in untreated CLL; not mutation-restricted for venetoclax-obinutuzumab or ibrutinib-venetoclax in the cited recommendation wording; Untreated adult CLL for venetoclax-obinutuzumab and ibrutinib-venetoclax; untreated and previously treated CLL for acalabrutinib; untreated high-risk/FCR-BR-unsuitable or relapsed/refractory CLL for zanubrutinib. · NICE technology appraisal guidance is England/NHS-context and includes commercial-arrangement conditions. It does not establish access in all devolved UK nations, individual eligibility, contraindications, or sequencing preference. Confidence/conflicts: High for NICE England recommendation wording; no source conflict recorded.
  • Venetoclax (Venclyxto) with azacitidine; gilteritinib (Xospata); quizartinib (Vanflyta); ivosidenib (Tibsovo) with azacitidine[58]NICE recommendedFLT3-ITD for quizartinib; FLT3 mutation for gilteritinib; IDH1 R132 mutation for ivosidenib; not mutation-restricted for venetoclax plus azacitidine; Untreated AML when intensive chemotherapy is unsuitable; relapsed/refractory FLT3-mutated AML; newly diagnosed FLT3-ITD-positive AML induction/consolidation/maintenance; untreated IDH1 R132-mutated AML when standard intensive induction is not suitable. · NICE technology appraisals are England context and often depend on commercial arrangements. Devolved-nation access and local NHS implementation may differ; appraisal text must be checked for detailed criteria and stopping/funding conditions. Confidence/conflicts: High for NICE England-context appraisal existence and broad scope; detailed recommendation restrictions should be read before patient-facing reuse.
  • brexucabtagene autoleucel (Tecartus)[59]NICE recommendedB-cell precursor ALL; age 26 years and over; People 26 years and over with relapsed or refractory B-cell ALL in the NICE England context. · Managed access and patient access scheme terms are not public. NICE guidance does not guarantee immediate center availability or eligibility. Confidence/conflicts: High for NICE England Tecartus appraisal status. No conflict identified.
  • inotuzumab ozogamicin (Besponsa)[60]NICE recommendedCD22-positive B-cell precursor ALL; adult setting; Adults with relapsed or refractory CD22-positive B-cell precursor ALL in the NICE England context. · NICE TA541 is adult-focused. Pediatric Besponsa status and devolved-nation implementation require separate checks. Confidence/conflicts: High for NICE England adult Besponsa appraisal status. No conflict identified.

Japan

  • Asciminib (Scemblix); bosutinib (Bosulif); nilotinib (Tasigna); ponatinib (Iclusig); dasatinib (Sprycel); imatinib (Glivec historical related entry); conditioning before allogeneic hematopoietic stem cell transplantation[61]EMA authorisedBCR-ABL1 / Philadelphia chromosome context; resistance or intolerance to prior TKIs for several entries; chronic or accelerated phase for nilotinib pediatric dosage entry; newly diagnosed chronic phase for bosutinib indication entry; Product-specific CML settings including newly diagnosed chronic phase, resistance/intolerance after prior therapy, chronic/accelerated phase, and allo-HSCT conditioning context. · PMDA approved-drug list verifies regulatory history but not current label details, reimbursement, mutation-specific selection, treatment-free remission monitoring, or individual eligibility. Current Japanese package inserts should be checked for each product. Confidence/conflicts: Medium-high for PMDA approval-list status; full current label detail remains active gap.
  • Blinatumomab (Blincyto); inotuzumab ozogamicin (Besponsa)[61]PMDA-approved (Japan)B-cell precursor/CD19-directed context for blinatumomab; CD22-positive for inotuzumab ozogamicin; Relapsed or refractory B-cell ALL for blinatumomab; relapsed or refractory CD22-positive ALL for inotuzumab ozogamicin, including pediatric dosage addition in PMDA list. · PMDA approved-drug list verifies Japan regulatory history but not current reimbursement, local access, sequencing, bridging-to-transplant use, or individual eligibility. Current Japanese package inserts should be checked before patient-facing reuse. Confidence/conflicts: High for PMDA approval-list status; current label/access remains active gap.
  • Gemtuzumab ozogamicin (Mylotarg); fludarabine; busulfan conditioning context; high-risk AML combination product entry[61]EMA authorisedCD33-positive for gemtuzumab ozogamicin historical entry; Relapsing/intractable CD33-positive AML for Mylotarg; relapsed/refractory AML for fludarabine; conditioning before allogeneic hematopoietic stem cell transplantation including AML for busulfan-related entry. · Some entries are older and require current Japanese label/status confirmation before patient-facing reuse. The conditioning entry is transplant-preparative, not a stand-alone AML treatment. Confidence/conflicts: Medium for older PMDA list entries; current package-insert/status refresh needed. Availability/reimbursement outside the approving regulator not established.
  • Gilteritinib (Xospata); quizartinib (Vanflyta)[61]PMDA-approved (Japan)FLT3 mutation for gilteritinib; FLT3-ITD mutation for quizartinib; Relapsed/refractory FLT3-mutated AML for gilteritinib; relapsed/refractory FLT3-ITD AML and newly diagnosed FLT3-ITD AML for quizartinib. · PMDA approved-drug list verifies regulatory history but not current reimbursement, local access, transplant sequencing, or individual eligibility. Current Japanese package inserts should be checked before reuse. Confidence/conflicts: High for PMDA approval-list status; product-label detail remains active gap.
  • Ivosidenib; venetoclax; azacitidine[61]PMDA-approved (Japan)IDH1 mutation-positive for ivosidenib; not mutation-restricted in PMDA list snippets for venetoclax and azacitidine AML entries; IDH1 mutation-positive AML for ivosidenib; AML contexts for venetoclax and azacitidine as PMDA list entries state, with line-of-therapy details requiring package-insert confirmation. · The PMDA list confirms Japan approval-list entries but does not provide full regimen combinations, eligibility, or line-of-therapy details in the extracted text. Current Japanese package inserts, reimbursement, and local hematology protocols remain active gaps. Confidence/conflicts: Medium-high for PMDA approval-list status; regimen and line-of-therapy specificity require label review.
  • Kymriah (tisagenlecleucel); Blincyto (blinatumomab); Besponsa (inotuzumab ozogamicin)[62]PMDA-approved (Japan)CD19-positive B-cell ALL for CAR-T/blinatumomab; CD22-positive ALL for inotuzumab; Relapsed/refractory Japan ALL advanced-therapy planning by CD19/CD22 marker, age, relapse history, and center access. · This is an option map, not sequencing guidance. Direct Japanese labels, reimbursement, and center-level availability remain active gaps. Confidence/conflicts: Medium-high for Japan advanced-therapy option map; some sources are company-published or Japanese-language and need direct-label refresh. No conflict identified. Primary source is in Japanese. English summary pending human review — confirm exact wording with your care team.
  • Pirtobrutinib (Jaypirca); zanubrutinib (Brukinsa); acalabrutinib (Calquence); venetoclax (Venclexta); ibrutinib (Imbruvica); obinutuzumab (Gazyva); rituximab (Rituxan-related entry)[61]PMDA-approved (Japan)BTK-inhibitor resistant or intolerant context for pirtobrutinib; CD20-positive context for obinutuzumab and rituximab; not otherwise mutation-restricted in the PMDA approved-drug list entries captured here; Relapsed/refractory CLL/SLL for pirtobrutinib, venetoclax, and earlier acalabrutinib/ibrutinib entries; BTK-inhibitor resistant or intolerant relapsed/refractory CLL/SLL for pirtobrutinib; CD20-positive CLL/SLL for obinutuzumab and CD20-positive CLL for rituximab. · The PMDA list verifies approval-list history and indication wording, not current reimbursement, package-insert details, institution access, sequencing preference, or individual suitability. Current Japanese labels and local formulary status remain separate checks. Confidence/conflicts: High for PMDA approval-list wording; no conflict recorded, but product-label and reimbursement details remain gaps.
  • acalabrutinib (Calquence), as monotherapy or with obinutuzumab in evidence context[63]ApprovedNot restricted by biomarker in fetched source; TP53/17p status should still be considered clinically; Adult treatment-naive CLL/SLL in Japan; prior Japan approval for relapsed/refractory CLL/SLL noted by the source. · This is a company source rather than a PMDA package insert or Japanese reimbursement listing. Current label wording, reimbursement, and hospital formulary status should be verified locally. Confidence/conflicts: Medium-high for Japan approval signal; direct PMDA label/reimbursement remains a gap. No conflict identified. A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
  • azacitidine (Vidaza)[64]Approvednot mutation-restricted in the fetched approval announcement; Treatment of patients with myelodysplastic syndromes; the fetched source does not restrict to a specific risk group in the announcement text. · This is a company announcement of MHLW approval and launch, not a current PMDA package insert or NHI price file. Current indication wording, risk-category use, reimbursement, and hospital protocol should be verified from Japanese official labeling. Confidence/conflicts: Medium-high for Japan approval/launch signal; current label/NHI details remain gaps. No conflict identified. A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
  • azacitidine (Vidaza)[61]PMDA-approved (Japan)not biomarker-restricted in the fetched PMDA approval-summary text; Japan approval-summary context for MDS broadly; the fetched official source does not state risk-category or transplant-eligibility wording. · The PMDA approval list supports official approval dates and broad indication summaries but not current detailed label wording, dosing conditions, or NHI pricing. The 2021 AML extension should not be misread as expanding MDS eligibility beyond the original summary. Confidence/conflicts: High for PMDA approval-summary dates and indication scope. No conflict identified; current insert/NHI details remain a gap. Availability/reimbursement outside the approving regulator not established.
  • blinatumomab (Blincyto)[65]ApprovedB-cell ALL; CD19-directed CD3 bispecific T-cell engager context; Relapsed or refractory B-cell ALL in Japan. · This is a company press release reporting MHLW approval, not a directly fetched Japanese label or reimbursement source. It should not be used to infer current payer access or hospital availability. Confidence/conflicts: Medium-high for Japan approval signal; direct MHLW/PMDA label remains a gap. No conflict identified. A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
  • inotuzumab ozogamicin (Besponsa)[66]PMDA-approved (Japan)CD22-positive ALL; adult and pediatric expansion context; Relapsed or refractory CD22-positive ALL in Japan; adult approval and pediatric expansion context. · PMDA sources are Japanese-language and require human review before direct patient-facing reuse. PubMed milestone article supports the pediatric approval timeline but is not a regulator label. Confidence/conflicts: Medium-high for adult and pediatric Japan approval status; Japanese-language PMDA content needs human review. No conflict identified. Primary source is in Japanese. English summary pending human review — confirm exact wording with your care team. Availability/reimbursement outside the approving regulator not established.
  • lenalidomide (Revlimid)[61]PMDA-approved (Japan)deletion 5q cytogenetic abnormality; Japan approval-summary context for del(5q)-associated MDS; exact current package-insert wording, transfusion criteria, and reimbursement terms were not fetched in this cycle. · This PMDA approved-drug list is an official approval summary, not the current full package insert or NHI reimbursement file. Do not infer present-day prescribing restrictions, formulary status, or hospital availability beyond the approval summary. Confidence/conflicts: High for Japan approval-summary facts from PMDA. No conflict identified, but current insert/NHI specifics remain unverified.
  • luspatercept (Reblozyl)[67]Approvedlower-risk MDS anemia context; ESA-naive first-line signal in fetched BMS source; ring-sideroblast criteria not fully Japan-specific in fetched source; First-line treatment of anemia associated with lower-risk MDS; Japanese article describes lower-risk MDS anemia. · The approval signal is from company and peer-reviewed secondary sources, not a direct Japanese PMDA/MHLW package insert. Current Japan label details, NHI price, ESA/ring-sideroblast restrictions, and transfusion-dependence criteria must be verified. Confidence/conflicts: Medium for Japan approval signal due to secondary/company sources; direct PMDA/MHLW label needed. No conflict identified. A secondary/company source is present; the cited primary source is the regulator/HTA/official record. Availability/reimbursement outside the approving regulator not established.
  • luspatercept (Reblozyl)[61]PMDA-approved (Japan)no mutation biomarker stated in the fetched PMDA approval-summary text; Japan approval-summary context for anemia associated with MDS; the fetched source does not specify lower-risk wording, ring-sideroblast status, ESA sequence, or transfusion thresholds. · This official PMDA approval summary closes the prior company-source gap for Japanese approval, but it is not the current package insert and does not establish NHI pricing, exact label restrictions, or center-level availability. Confidence/conflicts: High for Japan approval-summary facts from PMDA. This supersedes the earlier company/secondary approval signal as the primary source for approval status; current insert/NHI specifics still need verification. Availability/reimbursement outside the approving regulator not established.
  • rasburicase[68]Standard option (per Pharmaceuticals and Medical Devices Agency)tumor lysis / hyperuricemia risk context; Supportive management for leukemia or malignant lymphoma patients at high risk for hyperuricemia and tumor lysis around chemotherapy initiation; Burkitt lymphoma is a high-turnover malignant lymphoma context to discuss with the oncology team. · This is supportive-care evidence from a PMDA regulatory review, not disease-directed Burkitt therapy. Use depends on tumor-lysis risk assessment, renal/metabolic status, contraindications such as G6PD deficiency where relevant, local label, and institutional supportive-care protocols. Confidence/conflicts: Medium-high for Japan supportive-care regulatory evidence; direct current package insert and Burkitt protocol integration remain gaps. No conflict identified.
  • tisagenlecleucel (Kymriah)[62]PMDA-approved (Japan)CD19-positive B-cell ALL; pediatric/adolescent and young adult context in PMDA review history; Japan PMDA-reviewed CD19-positive B-cell ALL CAR-T context, especially pediatric/AYA relapsed or refractory B-ALL. · This entry uses a PMDA review report and does not by itself establish current reimbursement, manufacturing slot availability, or center qualification. Confidence/conflicts: High for PMDA-reviewed Kymriah CD19-positive B-ALL context. No conflict identified.

Korea

  • blinatumomab (Blincyto)[69]ApprovedMRD-positive B-cell precursor ALL; relapsed or refractory B-cell precursor ALL; MRD-positive complete-remission setting, relapsed/refractory B-cell precursor ALL, and HIRA-reviewed consolidation therapy for Ph-negative precursor B-cell ALL. · The product-information source is English-language but hosted by Amgen Korea; exact MFDS database record was not fetched in this batch. HIRA states coverage criteria may differ within the MFDS-approved indication and may change during subsequent procedures. Confidence/conflicts: High for Korea Blincyto label and HIRA consolidation reimbursement signal; medium for current full MFDS status because the direct MFDS product page was not fetched. No conflict identified.
  • blinatumomab (Blincyto); tisagenlecleucel (Kymriah)[69]ApprovedB-cell precursor ALL; CD19 target for blinatumomab and CAR-T; Philadelphia chromosome-negative consolidation pathway for HIRA blinatumomab review; Korea ALL advanced-option map spanning antibody immunotherapy and CD19 CAR-T access research. · This map does not establish sequencing, superiority, eligibility, center capacity, current detailed reimbursement restrictions, or availability at a specific hospital. Korean-language sources require human review before reuse. Confidence/conflicts: Medium-high for Korea blinatumomab/Kymriah map; direct current MFDS/HIRA detail gaps remain. No conflict identified. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
  • fludarabine/cyclophosphamide/rituximab (FCR), chlorambucil, obinutuzumab plus chlorambucil (GC)[70]Standard option (per The Korean Journal of Internal Medicine)TP53 aberration status discussed as under-tested in Korea; source reports TP53 aberrations in 7.0% of evaluable patients; First-line systemic therapy patterns in Korea from 2010-2021 cohort data. · This is real-world retrospective evidence, not a current MFDS label or HIRA reimbursement rule. It predates several newer targeted-agent approvals and reimbursement changes. Confidence/conflicts: Medium-high for historical Korea treatment/reimbursement context; current label/reimbursement needs refresh. No conflict identified.
  • ibrutinib (Imbruvica)[70]ApprovedTP53 aberration and del(17p) status noted as relevant but incompletely tested in source cohort; Second-line or later Korean CLL/SLL treatment context after reimbursement in 2018. · The article reflects data through 2021 and is not a current HIRA reimbursement bulletin. It should not be used to infer current first-line reimbursement or post-BTK sequencing. Confidence/conflicts: Medium-high for Korea second-line ibrutinib reimbursement-era context; current HIRA/MFDS details remain gaps. No conflict identified.
  • imatinib, dasatinib, nilotinib; second-line TKIs; TKI plus cytotoxic agents and hematopoietic cell transplantation in advanced stages[71]Standard option (per Korean Journal of Medicine / Korean Society of Hematology CML Working Party)Philadelphia chromosome / BCR-ABL1-positive CML; ABL tyrosine kinase mutation status after failure/intolerance; Newly diagnosed chronic-phase CML first-line TKI therapy; second-line TKI after failure/intolerance; advanced-stage CML treatment framework. · The guideline article is older (2014) and should be refreshed against current Korean labels and HIRA criteria before patient-facing use. It supports a Korea treatment/reimbursement framework but not current product-by-product status for newer TKIs. Confidence/conflicts: Medium for Korea framework because source is authoritative but dated. No conflict identified.
  • quizartinib (Vanflyta)[72]ApprovedFLT3-ITD mutation; Korean epidemiology context from source; Evidence basis for Korean adult newly diagnosed FLT3-ITD-positive AML approval signal. · The article's trial summary is not a Korean protocol or eligibility rule. Trial-effect estimates should be checked against the primary publication or official label before patient-facing use. Confidence/conflicts: Medium for trial evidence details because this is a news report rather than the primary publication or MFDS label. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • quizartinib (Vanflyta) launch/access planning[72]ApprovedFLT3-ITD mutation-positive AML; poor-prognosis context reported in Korea source; Korea launch/access planning after MFDS marketing approval for adult newly diagnosed FLT3-ITD-positive AML. · Launch timing is an access signal only. Reimbursement, hospital formulary inclusion, and actual drug supply require separate Korean sources. Confidence/conflicts: Medium for launch/access timing; approval signal is stronger than reimbursement/access inference. No conflict identified.
  • quizartinib (Vanflyta) with standard cytarabine and anthracycline induction, standard cytarabine consolidation, followed by maintenance monotherapy[72]ApprovedFLT3-ITD mutation-positive AML; Adult newly diagnosed FLT3-ITD-positive AML in Korea; induction, consolidation, and post-consolidation maintenance. · This is an English-language trade news article reporting a Daiichi Sankyo Korea/MFDS approval signal, not the direct MFDS label or reimbursement decision. It should not be used to infer Korean payer access or hospital availability. Confidence/conflicts: Medium-high for Korean approval signal; direct MFDS label/reimbursement source remains a gap. No conflict identified.
  • radotinib (Supect)[73]FDA-approvedBCR-ABL1-positive CML; mutation profile matters, especially T315I resistance caveat in the review; Chronic-phase CML in newly diagnosed/upfront and salvage/resistance-intolerance settings, as described by the sources. · These are peer-reviewed and company sources, not direct current MFDS label text. The review notes mutation sensitivity limitations including T315I; do not infer suitability without mutation and clinical review. Confidence/conflicts: Medium-high for Korea radotinib approval signal; direct MFDS label remains a gap. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • targeted agents including ibrutinib, acalabrutinib, idelalisib, duvelisib, and venetoclax; clinical trials[70]Standard option (per The Korean Journal of Internal Medicine)del(17p), TP53 mutation, IGHV status; Risk-stratification before treatment selection; relapsed/refractory targeted-agent insurance context in Korea during the study period. · This is not a current policy statement. Current Korean TP53 testing reimbursement, targeted-agent indications, and trial availability need direct HIRA/MFDS or center confirmation. Confidence/conflicts: Medium for Korea biomarker/reimbursement context because source is dated and observational. No conflict identified.
  • tisagenlecleucel (Kymriah)[74]EMA authorisedB-cell ALL; CD19 CAR-T context; Pediatric/young adult age 25 or younger R/R B-cell ALL after transplant relapse, second or later relapse, or refractory disease; reimbursed Korea access signal for B-cell ALL. · The Korea drug-review PDF and KBR article contain Korean-language content; mark for human review before patient-facing reuse. The exact current MFDS product page and current HIRA detailed criteria remain follow-up checks. Confidence/conflicts: Medium-high for Korea Kymriah ALL approval and reimbursement signal; direct current MFDS/HIRA detailed criteria remain gaps. No conflict identified. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.

Australia

  • antifungal prophylaxis and infection-risk supportive care during intensive or immunosuppressive therapy[75]Standard option (per eviQ / Cancer Institute NSW)not mutation-specific; High-risk MDS or hematology treatment settings where invasive fungal disease risk is clinically relevant. · eviQ states antifungal prophylaxis should not be used routinely in all neutropenic patients and should be individualized. This is supportive-care guidance, not proof of reimbursement or a patient-specific prescription. Confidence/conflicts: High for Australian supportive-care guidance; individual use requires clinician judgment. No conflict identified.
  • azacitidine (Vidaza)[76]Standard option (per eviQ / Cancer Institute NSW)not mutation-specific; eviQ cites higher-risk MDS/IPSS intermediate-2 or high-risk study context; Myelodysplastic syndrome or CMML protocol context; evidence discussion highlights higher-risk MDS. · eviQ is a clinical protocol source and does not itself establish TGA approval, PBS funding, or individual eligibility. Exact Australian funding and route/schedule depend on local protocol and payer rules. Confidence/conflicts: High for Australian protocol listing; PBS/TGA access remains a gap. No conflict identified.

China

  • FLT3 mutation retesting to inform gilteritinib (Xospata) discussion[77]NMPA-approved (China)FLT3 mutation status may change over the course of AML treatment and after relapse; Relapsed or refractory AML molecular reassessment before considering gilteritinib. · This entry records a testing/planning point from the approval report. It does not specify which diagnostic assays are approved or available in China. Confidence/conflicts: Medium-high for FLT3 retesting rationale as reported in the China approval release; direct Chinese guideline/label detail remains a gap. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • asciminib (Scemblix)[78]ApprovedPh+ / BCR::ABL1-positive CML-CP; T315I and prior-TKI contexts may differ by country label; China approval signal for newly diagnosed adult Ph+ CML-CP; China real-world study for newly diagnosed CML-CP initiating asciminib. · Direct NMPA label and reimbursement/procurement status were not fetched. The trial listing includes a general investigational disclaimer and should not be used to infer individual eligibility or routine availability. Confidence/conflicts: Medium for China asciminib approval and real-world study signal; direct NMPA label remains a priority gap. No conflict identified. based on a company press release — confirm against the regulator label A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
  • blinatumomab (Blincyto)[79]NMPA-approved (China)CD19-positive B-cell precursor ALL; adult relapsed/refractory context; Adult relapsed/refractory CD19-positive or precursor B-cell ALL in China. · Direct NMPA label, procurement, and reimbursement were not fetched in this cycle. The approval signal comes from company/specialty secondary sources and should be refreshed against the NMPA database before patient-facing reuse. Confidence/conflicts: Medium for adult China blinatumomab approval signal because direct NMPA label was not fetched. No conflict identified.
  • blinatumomab (Blincyto)[80]NMPA: conditionally approvedCD19-positive B-cell precursor ALL; pediatric relapsed/refractory context; Pediatric relapsed/refractory CD19-positive B-cell precursor ALL in China. · This is not a direct NMPA label. Pediatric age boundaries, dosing, access, and reimbursement require direct Chinese product-information verification. Confidence/conflicts: Medium for pediatric China blinatumomab approval signal because direct NMPA label was not fetched. No conflict identified.
  • blinatumomab (Blincyto); inaticabtagene autoleucel (CNCT19)[80]NMPA: conditionally approvedCD19-positive B-cell precursor ALL for blinatumomab; B-cell ALL/CD19 CAR-T context for CNCT19; China relapsed/refractory B-cell ALL option mapping for immunotherapy and CAR-T discussion. · Direct NMPA label/procurement confirmation remains a priority gap. Do not infer interchangeability, sequencing, or patient eligibility. Confidence/conflicts: Medium for China advanced-therapy map because all source-confirmed claims need direct NMPA label refresh. No conflict identified.
  • flumatinib mesylate[81]EMA authorisedPhiladelphia chromosome-positive / BCR::ABL1-positive CML; Newly diagnosed CML in chronic phase in China; first-line CML-CP context per company/guideline summary. · Direct NMPA label and current reimbursement/procurement status were not fetched. Hansoh is a company source; the Haematologica source is peer-reviewed but not a regulator label. Do not infer equivalence or superiority beyond source statements. Confidence/conflicts: Medium-high for China flumatinib approval/guideline signal; direct NMPA label remains a gap. No conflict identified.
  • gilteritinib (Xospata)[77]Conditionally approvedFLT3 mutation-positive AML detected by a fully validated test; FLT3-ITD and FLT3-TKD mutation context; Adult relapsed or refractory FLT3-mutated AML in China. · This is a company press release reporting an NMPA decision, not a directly fetched NMPA label or reimbursement/procurement source. It should not be used to infer hospital availability, payer access, or first-line use in China. Confidence/conflicts: Medium-high for NMPA conditional-approval claim because the source is company-published; direct NMPA label remains a gap. No conflicting source identified.
  • inaticabtagene autoleucel (CNCT19)[82]NMPA-approved (China)B-cell ALL; CD19 CAR-T context; Relapsed or refractory B-cell ALL in China. · This is a specialty news report and not a direct NMPA label. Exact age range, indication wording, manufacturing center, and reimbursement/procurement require direct Chinese verification. Confidence/conflicts: Medium for China CNCT19 approval signal; direct NMPA label and product-specific patient criteria remain gaps. No conflict identified.
  • lisaftoclax (APG-2575)[83]NMPA-approved (China)Prior systemic therapy including a BTK inhibitor; Adult CLL/SLL after at least one systemic therapy including a BTK inhibitor. · Direct NMPA label, Chinese package insert, reimbursement/procurement, and provincial access were not fetched. This is a specialty-news source and should be confirmed with local regulator or hospital pharmacy documentation. Confidence/conflicts: Medium for China approval signal; direct NMPA label remains a gap. No conflict identified.
  • pirtobrutinib (Jaypirca)[84]NMPA-approved (China)Prior systemic therapy including a BTK inhibitor; Adult R/R CLL/SLL after at least one systemic therapy line including a BTK inhibitor. · Direct NMPA label, reimbursement/procurement, and hospital formulary status were not fetched. PRNewswire is a company-distributed announcement; Lymphoma Hub is a specialty-news summary, not the regulator label. Confidence/conflicts: Medium-high for China approval signal; direct NMPA label remains a gap. No conflict identified.
  • zanubrutinib (Brukinsa)[85]NMPA: conditionally approved17p deletion status discussed in SEQUOIA evidence context; source does not limit approval to that biomarker; Previously untreated adult CLL/SLL and adult CLL/SLL after at least one prior therapy in China. · Direct NMPA label and reimbursement/procurement were not fetched. OncLive is a specialty oncology news source; current label boundaries should be verified locally. Confidence/conflicts: Medium for China approval signal; direct NMPA label remains a gap. No conflict identified.

Russia

  • Azacitidine/hypomethylating therapy, AML-like induction in selected contexts, allogeneic hematopoietic stem-cell transplantation evaluation, clinical trials and supportive care[86]Standard option (per MedElement clinical recommendations portal / Russian MDS/MDS-MPN clinical recommendations mirror)Risk category, blast percentage, cytogenetic/molecular risk and transplant fitness are key planning factors.; Higher-risk adult MDS or MDS/MPN treatment planning, including transplant and non-transplant pathways. · The fetched source supports the Russian guideline existence and scope; exact higher-risk regimen tables, transplant criteria and drug access require further line-by-line review before patient-facing reuse. Confidence/conflicts: Medium-low for regimen specifics; source verifies Russia guideline scope but this cell needs deeper table extraction. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • BCR-ABL tyrosine kinase inhibitor (TKI) therapy; dasatinib named in the Russian guideline context; chemotherapy or maintenance combinations by protocol[87]Standard option (per MedElement clinical recommendations portal / Russian adult ALL clinical recommendations mirror)BCR::ABL1 / Philadelphia chromosome positive.; Adult Ph-positive ALL treatment and maintenance framework. · Guideline support does not prove reimbursement, procurement, or individual suitability for a specific TKI. Confirm the exact BCR::ABL1 transcript, TKI availability, interaction profile, mutation/resistance status, and transplant strategy locally. Confidence/conflicts: Medium for targeted treatment framework because the fetched guideline output supports TKI strategy, but product-level access and direct regulator labels are not captured. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • BCR-ABL tyrosine kinase inhibitors (TKIs), including first- and second-generation TKI classes; imatinib switch/escalation context[88]Standard option (per MedElement clinical recommendations portal / Russian CML clinical recommendations mirror)BCR::ABL1 response milestones; BCR::ABL1 mutation testing when inadequate response is not explained by adherence.; CML TKI treatment, response monitoring, and inadequate-response treatment-change framework. · The source does not provide product-specific regulator labels, reimbursement, procurement, or brand-level availability. It should not be read as saying every TKI is available or suitable for every patient; comorbidities, toxicity, phase, mutation profile, and adherence matter. Confidence/conflicts: Medium for Russia availability class statement and guideline framework; product-specific labels/procurement remain source-pending. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • BTK inhibitors acalabrutinib, zanubrutinib, ibrutinib; venetoclax-containing combinations; selected chemoimmunotherapy re-treatment/alternative regimens; allogeneic hematopoietic stem-cell transplantation consideration in selected younger high-risk complete-remission contexts[89]Standard option (per MedElement clinical recommendations portal / Russian CLL/SLL clinical recommendations mirror)del(17p), TP53 mutation and complex karyotype in relapse; early vs late relapse timing after chemoimmunotherapy.; Relapsed CLL/SLL, including early relapse, late relapse, and high-risk marker contexts. · Guideline support does not establish Russian product registration, reimbursement, procurement, or transplant-center acceptance. Allogeneic transplant is recorded as a selected consolidation discussion point, not routine eligibility. Confidence/conflicts: Medium for guideline framework; direct regulator labels and transplant access remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Bone marrow evaluation, cytogenetic/molecular risk assessment, risk-stratified treatment planning[86]Standard option (per MedElement clinical recommendations portal / Russian MDS/MDS-MPN clinical recommendations mirror)Cytopenias, dysmyelopoiesis, AML transformation risk; del(5q) and other categories listed by ICD/clinical classification.; Diagnostic confirmation and treatment planning in adult MDS/MDS-MPN. · Russian-language guideline mirror; human review is needed. This planning cell does not establish availability of every cytogenetic or molecular assay at each center. Confidence/conflicts: Medium-high for Russian guideline diagnostic/risk framing; direct official PDF remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • CAR-T therapy; tisagenlecleucel where specified in adult/AYA source; anti-CD19 CAR-T center-produced product[90]Standard option (per LegalActs mirror of Russian Ministry of Health clinical recommendations)Precursor B-cell ALL; CD19 CAR-T context; Pediatric relapsed/refractory precursor B-ALL CAR-T consideration and Russian center-produced CD19 CAR-T access-research pathway. · Russian-language sources require human review. The guideline recommendation and center service description do not establish nationwide availability, reimbursement, wait time, or patient eligibility. Confidence/conflicts: Medium for Russian pediatric CAR-T guideline/access map. No conflict identified, but product identity and center/funding details remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Cladribine; interferon alfa-2b or peginterferon alfa-2a prephase in neutropenia contexts; possible rituximab addition for extramedullary disease contexts[91]Standard option (per MedElement clinical recommendations portal / Russian HCL clinical recommendations mirror)BRAF V600E is part of classic HCL biology but the first-line purine-analog statement is not mutation-gated in the fetched source.; First treatment of verified adult HCL when treatment-start criteria are present. · This is a guideline pathway, not a direct Russian product-registration, procurement, reimbursement, or individualized eligibility source. Dosing details are intentionally not surfaced here. Confidence/conflicts: Medium-high for treatment-start and cladribine/interferon framework; direct labels/procurement remain gaps. No conflict recorded. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Cytogenetic testing, PCR and/or FISH for BCR::ABL1; molecular monitoring[88]Standard option (per MedElement clinical recommendations portal / Russian CML clinical recommendations mirror)t(9;22)(q34;q11), Philadelphia chromosome, BCR::ABL1 transcript; p210 typical transcripts and atypical BCR::ABL1 transcript contexts.; Diagnosis and ongoing molecular monitoring in CML. · Russian-language guideline mirror; human review is needed before patient-facing reuse. The source supports the testing framework but not the availability of every assay in every region or laboratory. Confidence/conflicts: Medium-high for Russian guideline testing framework; direct Ministry PDF remains a follow-up gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Cytogenetic/FISH and molecular testing; MRD monitoring[87]Standard option (per MedElement clinical recommendations portal / Russian adult ALL clinical recommendations mirror)BCR::ABL1 / Philadelphia chromosome, KMT2A, BCR::ABL1-like alterations including CRLF2, ABL1, ABL2, JAK2, EPOR and PDGFRB contexts; MRD monitoring markers for B-cell ALL.; Diagnostic workup, risk/treatment planning, and response monitoring in adult ALL. · Russian-language guideline mirror; human review is needed before patient-facing reuse. The source supports testing/monitoring as a guideline framework but does not establish access to every assay at every Russian center. Confidence/conflicts: Medium-high for Russian guideline testing framework; original Ministry-hosted document and lab access remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Diagnostic confirmation and BRAF V600E molecular testing to guide HCL treatment discussion[91]Standard option (per MedElement clinical recommendations portal / Russian HCL clinical recommendations mirror)BRAF V600E; immunophenotype markers including CD19, CD20, CD22, CD25, CD11c, CD103, CD123 and related HCL markers.; Diagnostic confirmation and treatment planning for suspected or confirmed adult HCL, including relapse/resistant contexts. · Russian-language guideline mirror; human clinical-language review is needed. This finding does not establish which assays are available at a particular Russian center. Confidence/conflicts: Medium-high for guideline framework; direct Ministry PDF and assay-access details remain gaps. No conflict recorded. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Gilteritinib; cytostatic chemotherapy combinations; pyrimidine analogs azacitidine or decitabine; venetoclax; sorafenib in selected FLT3/high-FLT3-expression contexts[92]Standard option (per MedElement clinical recommendations portal / Russian AML clinical recommendations mirror)FLT3 mutation; FLT3-ITD and FLT3-TKD retesting at relapse/refractory disease is specifically recommended in the source.; Relapsed/refractory FLT3-mutated AML; selected FLT3/high-expression AML contexts. · This is a guideline recommendation, not a Russian regulator label, reimbursement, or procurement confirmation. Gilteritinib, venetoclax, azacitidine, decitabine, and sorafenib access must be verified separately for a treating center. Confidence/conflicts: Medium-high for Russian guideline recommendation; product-specific regulator/procurement confidence remains limited. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Immunophenotyping, cytogenetic/molecular risk testing, CLL prognostic assessment[89]Standard option (per MedElement clinical recommendations portal / Russian CLL/SLL clinical recommendations mirror)del(17p), TP53 mutation, IGHV mutation status, beta-2 microglobulin; diagnostic immunophenotype CD19, CD5, CD23, CD20, kappa/lambda and optional CD43, CD200, CD79b, CD81.; Diagnosis, prognostic assessment and treatment planning in CLL/SLL. · Russian-language guideline mirror; human review is needed before patient-facing reuse. The source supports a testing framework but does not establish assay availability at every Russian center. Confidence/conflicts: Medium-high for Russian guideline diagnostic/prognostic framework; direct official PDF remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Infection workup and antibacterial management; splenectomy in relapse dominated by splenomegaly; systemic therapy after splenectomy as needed[91]Standard option (per MedElement clinical recommendations portal / Russian HCL clinical recommendations mirror)No biomarker restriction for supportive infection-management and splenectomy context; BRAF V600E remains relevant to broader HCL planning.; HCL supportive care during infection/neutropenia; relapsed HCL with splenomegaly-dominant presentation. · Supportive-care and surgical pathways depend on patient condition, infection severity, neutrophil count, local surgical capacity, and systemic-therapy plan. This finding is not a recommendation for surgery or antibiotics for any individual. Confidence/conflicts: Medium-high for guideline pathway; direct center capacity and product availability remain gaps. No conflict recorded. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Intensive multi-agent chemotherapy frameworks including Hyper-CVAD and Russian ALL-2009 / ALL-2016 protocol contexts; maintenance therapy after intensive phases[87]Standard option (per MedElement clinical recommendations portal / Russian adult ALL clinical recommendations mirror)Philadelphia-negative / BCR::ABL1-negative context as described by guideline section.; Initial adult Ph-negative ALL treatment, consolidation and maintenance framework. · This finding records protocol families and treatment frameworks only; it does not provide dosing, schedule, eligibility, or center-level protocol availability. Age, fitness, subtype, MRD, infection risk, transplant planning, and organ function affect local protocol choice. Confidence/conflicts: Medium-high for Russian guideline chemotherapy framework; no dosing details captured by design. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Molecular testing and allogeneic HSCT decision support[93]Standard option (per MedElement clinical recommendations portal / Russian Ph-negative MPN clinical recommendations mirror)JAK2, MPL, CALR; additional ASXL1, EZH2, TET2, SRSF2, SF3B1, IDH1 and IDH2 testing in source for diagnostic verification and allogeneic HSCT decision-making in primary myelofibrosis.; Diagnostic verification and transplant decision-making for Ph-negative MPN/primary myelofibrosis. · Russian-language guideline mirror; human review is needed. Testing availability and transplant acceptance are not inferred for every center. Confidence/conflicts: Medium-high for Russian molecular/transplant-planning framework; direct official PDF/procurement remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Molecular-genetic testing; intensive induction chemotherapy "7+3"; gemtuzumab ozogamicin addition in selected CD33-positive favorable/intermediate molecular-risk and FLT3-negative context; FLT3 inhibitors such as midostaurin or sorafenib added from induction in FLT3-mutated AML; allogeneic hematopoietic stem-cell transplantation consideration in high-risk contexts[92]Standard option (per MedElement clinical recommendations portal / Russian AML clinical recommendations mirror)NPM1, CEBPA, FLT3, TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, ZRSR2 and other molecular markers listed for risk/treatment planning; FLT3-ITD/TKD retesting in relapsed/refractory disease.; Initial adult AML diagnosis, induction, risk stratification, and post-remission/transplant planning. · Russian-language guideline mirror; human review is needed before patient-facing reuse. The source does not prove product-specific reimbursement/procurement for each named agent, and treatment depends on age, performance status, cytogenetic/molecular risk, donor availability, and complications. Confidence/conflicts: Medium-high for guideline framework; direct Ministry/original PDF and product access remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Risk-stratified MPN management framework; ruxolitinib/JAK-inhibitor and allogeneic transplant access to be verified in direct labels/procurement[93]Standard option (per MedElement clinical recommendations portal / Russian Ph-negative MPN clinical recommendations mirror)Primary myelofibrosis and Ph-negative MPN classification; JAK2/MPL/CALR and high-risk mutation context.; Russia guideline-level MPN/MF management framework. · Product-specific Russian labels, reimbursement, procurement and transplant-center pathways remain unverified and should be researched in a later cell before surfacing as routine access. Confidence/conflicts: Medium for guideline-scope framework; direct treatment-regimen extraction remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Supportive care with red-cell/platelet transfusions, iron overload monitoring/chelation, erythropoiesis-stimulating approaches, lenalidomide in del(5q)-type contexts where appropriate[86]Standard option (per MedElement clinical recommendations portal / Russian MDS/MDS-MPN clinical recommendations mirror)del(5q), ring sideroblast/SF3B1 and erythropoietin-response contexts should be checked where relevant; exact source-supported details require human review.; Lower-risk MDS anemia/supportive-care planning. · This entry intentionally avoids detailed Russian regimen claims that require line-by-line human review. Access to ESAs, chelation, transfusion support and lenalidomide varies by center and payer. Confidence/conflicts: Medium; broad guideline support verified, but detailed Russian-language therapeutic subclaims need human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Tisagenlecleucel (CAR-T; Kymriah in many jurisdictions, brand not confirmed by Russian source text)[87]ApprovedB-cell ALL; CAR-T context includes tisagenlecleucel; CD19 target implied by CAR-T product context in source comments.; Relapsed B-cell ALL in children and young adults up to and including age 25. · The source is a Russian-language guideline mirror and not a GRLS product-label page; registration, manufacturing slot, center accreditation, reimbursement, referral logistics, and bridging therapy need separate verification. Do not infer availability for adults older than 25 from this finding. Confidence/conflicts: Medium for Russia guideline statement and registration note; direct GRLS verification remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Treatment-free remission monitoring after TKI discontinuation; restart plan if molecular relapse occurs[88]Standard option (per MedElement clinical recommendations portal / Russian CML clinical recommendations mirror)BCR::ABL1 deep molecular response; molecular relapse threshold in guideline text.; Selected CML patients with stable deep molecular response after years of TKI therapy; post-discontinuation monitoring. · This is not a recommendation for any individual to stop therapy. It requires strict criteria, standardized molecular monitoring, rapid restart access, and specialist oversight; patient-facing reuse needs Russian human review and local confirmation. Confidence/conflicts: Medium-high for guideline concept; strict criteria and operational details need human review before surfacing. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Vemurafenib; rituximab; cladribine plus rituximab; bendamustine plus rituximab; interferon alfa-2b; obinutuzumab after prior rituximab in early relapse or refractory contexts[91]Standard option (per MedElement clinical recommendations portal / Russian HCL clinical recommendations mirror)BRAF V600E required in the fetched guideline text for vemurafenib-based options.; Relapsed/refractory HCL, especially BRAF V600E-mutated refractory disease and post-rituximab early relapse/refractory contexts. · Several medicines are marked in the source as off-label or context-dependent. This row does not verify Russian regulator labels, reimbursement, import/procurement, or treatment-center access for the named agents. Confidence/conflicts: Medium-high for Russian guideline mention; lower for real-world access because direct product and payer sources are unverified. No conflict recorded. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Venetoclax plus obinutuzumab; BTK inhibitors as a class in high-risk selection discussion[89]Standard option (per MedElement clinical recommendations portal / Russian CLL/SLL clinical recommendations mirror)del(17p), TP53 mutation, IGHV mutation status, complex karyotype and bulky nodes as risk/selection markers in the source discussion.; First-line CLL/SLL systemic treatment selection. · This is a treatment-selection framework, not a direct Russian regulator label or reimbursement confirmation for obinutuzumab, venetoclax or individual BTK inhibitors. Local access, infection risk, tumor-lysis risk, comorbidity and patient preference are not inferred. Confidence/conflicts: Medium for Russian guideline first-line framework; product access and exact regimen tables need direct official review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • allogeneic hematopoietic stem cell transplantation (allo-HSCT)[94]Standard option (per Medvestnik clinical recommendations mirror)BCR::ABL1-positive CML; T315I and response-failure contexts may affect sequencing; Multi-TKI failure, advanced phase, T315I after ponatinib/asciminib failure or inability to switch, and intolerance of available TKIs. · This is a guideline pathway, not a statement that a patient is transplant-eligible. Center referral, donor search, disease control, age/comorbidities, and Russian regional transplant capacity must be checked locally. Confidence/conflicts: Medium-high for Russian guideline pathway; transplant eligibility and access remain center-specific. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • asciminib (Scemblix)[94]Standard option (per Medvestnik clinical recommendations mirror)BCR::ABL1-positive CML-CP; T315I mutation or resistance/intolerance after two or more TKIs; CML-CP after two or more prior TKIs, and T315I-positive CML-CP context. · Russian-language source requires human review. Current Russia Scemblix GRLS label, public procurement, regional reimbursement, and availability by center were not verified. Confidence/conflicts: Medium-high for Russian guideline recommendation; direct label/procurement remains a gap. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • blinatumomab; inotuzumab ozogamicin[95]ApprovedPh-negative B-ALL with persistent MRD; relapsed B-cell ALL; CD19 and CD22 target context; Adult persistent MRD after induction in Ph-negative B-ALL; adult relapsed B-cell ALL contexts. · Source is Russian-language and should receive human review before patient-facing reuse. This is a guideline signal, not a direct Roszdravnadzor/GRLS product-label or reimbursement confirmation. Some medicines are marked in the source as off-label (#) or essential-drug status (**) depending on item; preserve source-level flags. Confidence/conflicts: Medium-high for guideline recommendation; low for regulator/reimbursement status because direct Russian registry records were not fetched. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • blinatumomab; inotuzumab ozogamicin; nelarabine for T-ALL context[90]ApprovedPediatric precursor B-cell ALL (ВП-ОЛЛ); high-risk MRD; early relapse or persistent MRD; T-ALL relapse context separately addressed; Pediatric high-risk precursor B-ALL with high MRD after high-dose chemotherapy; pediatric early relapse or persistent MRD contexts; HSCT-bridging intent as stated by the guideline. · Russian-language source requires human review. Inotuzumab is marked with off-label source notation (#) in some pediatric passages; exact Russian pediatric label and funding status require direct registry/payer verification. Confidence/conflicts: Medium-high for pediatric guideline signal; low for direct label/reimbursement status because registry records were not fetched. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • erythropoiesis-stimulating agents including epoetin alfa, epoetin beta, or darbepoetin alfa[86]Standard option (per MedElement clinical recommendations portal / Russian MDS/MDS-MPN clinical recommendations mirror)low or intermediate-1 IPSS risk; hemoglobin <100 g/L; endogenous erythropoietin <500 mU/mL and/or limited red-cell transfusion need under 2 units per month; Lower-risk adult MDS anemia supportive treatment planning before or instead of other anti-anemia agents. · Russian-language guideline mirror; human review is required before patient-facing reuse. This guideline statement does not establish Russian GRLS registration, procurement, reimbursement, or patient-specific suitability. Confidence/conflicts: Medium-high for the Russia guideline recommendation thresholds and ESA framing from fetched lines; direct Russian label/procurement verification remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • granulocyte colony-stimulating factor added to erythropoiesis-stimulating therapy, including filgrastim[86]Standard option (per MedElement clinical recommendations portal / Russian MDS/MDS-MPN clinical recommendations mirror)lower endogenous erythropoietin and lower transfusion burden predict better response; MDS with ring sideroblasts is highlighted as a setting where add-on benefit is strongest; Lower-risk or ring-sideroblast MDS anemia support after inadequate ESA-alone response. · Russian-language guideline mirror; human review is required. This is a guideline-support statement, not confirmation of Russian product registration, procurement, or reimbursement for filgrastim use in MDS. Confidence/conflicts: Medium-high for the Russia guideline add-on G-CSF statement and ring-sideroblast emphasis from fetched lines; direct label/procurement verification remains unconfirmed. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • imatinib, dasatinib, nilotinib, bosutinib, asciminib, ponatinib[96]ApprovedBCR::ABL1-positive / Philadelphia chromosome-positive CML implied by CML TKI pathway; Broad Russia TKI availability map for CML; exact line depends on drug, phase, mutation, prior response, and guideline pathway. · This is a Russian-language patient-education source, not a GRLS product card, procurement record, or payer rule. Direct GRLS entries and regional procurement/reimbursement remain priority gaps. Confidence/conflicts: Medium for Russia broad TKI availability map; direct GRLS/procurement confirmation is still missing. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • lenalidomide[86]Standard option (per MedElement clinical recommendations portal / Russian MDS/MDS-MPN clinical recommendations mirror)low/intermediate-1 IPSS risk or very low/low/intermediate IPSS-R under 3.5; absence of unfavorable karyotype; TP53 mutation testing recommended before treatment; del(5q) transfusion dependence is highlighted as the most justified use case; Lower-risk adult MDS anemia after ineffective ESA therapy, especially transfusion-dependent del(5q) disease. · Russian-language guideline mirror; human review is required before reuse. This does not establish current Russian GRLS status, procurement, reimbursement, or whether lenalidomide is being used on- or off-label in a specific center. Confidence/conflicts: Medium-high for the guideline's lower-risk lenalidomide framing, dosing schedule, and TP53-testing caveat from fetched lines; direct Russian label/procurement verification remains unconfirmed. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • luspatercept[86]Standard option (per MedElement clinical recommendations portal / Russian MDS/MDS-MPN clinical recommendations mirror)no deletion of the long arm of chromosome 5; very low-, low-, or intermediate-risk by IPSS-R; prior lack of response to ESA or failure to meet ESA-treatment criteria; Lower-risk transfusion-dependent adult MDS anemia after ESA failure or ESA ineligibility. · Russian-language guideline mirror; human review is required before reuse. This is not proof of Russia GRLS registration, reimbursement, or local formulary supply for luspatercept. Confidence/conflicts: Medium-high for the guideline indication framing and dosing-escalation summary from fetched lines; direct Russian label and access verification remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • ponatinib (Iclusig)[94]Standard option (per Medvestnik clinical recommendations mirror)BCR::ABL1-positive CML; T315I mutation or resistance/intolerance to second-generation TKIs; Resistant/intolerant after second-generation TKI or T315I-positive CML across chronic, accelerated, or blast phases. · Russian-language guideline mirror requires human language review. This entry does not verify a specific GRLS label, procurement route, payer status, or individual cardiovascular suitability. Confidence/conflicts: Medium-high for Russian guideline recommendation; access/reimbursement confidence remains medium-low. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • tisagenlecleucel; locally produced anti-CD19 CAR-T cellular product[95]EMA authorisedB-cell ALL; CD19 CAR-T context; age up to and including 25 for tisagenlecleucel recommendation; Relapsed B-cell ALL in patients up to and including 25 years; Russian academic/center-produced CD19 CAR-T pathway for selected B-cell hematologic malignancies including ALL. · Russian-language source requires human review. The NMIC Radiology page is a center/service description and not a national regulator label. Do not infer access outside the named center pathway or eligibility for any individual. Confidence/conflicts: Medium for Russia CAR-T option map; the guideline states registration for tisagenlecleucel while the center page describes a locally manufactured cell product, so product identity/access pathways must not be merged. No direct conflict. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team. Availability/reimbursement outside the approving regulator not established.

Thailand

  • Acalabrutinib (Calquence), alone or with obinutuzumab in untreated CLL[97]ApprovedNot biomarker-restricted in fetched Calquence indication text; high-risk features discussed in clinical-study sections include 17p deletion, 11q deletion, TP53 mutation and unmutated IGHV.; Previously untreated adult CLL; adult CLL after at least one prior therapy. · Product information does not establish reimbursement, local availability of obinutuzumab, or suitability for a specific patient. The fetched label is for hard capsules and includes interaction and safety requirements that should be handled by clinicians. Confidence/conflicts: High for Thai product-information indication text; no payer/access claim made.
  • Asciminib (Scemblix)[98]ApprovedT315I mutation is a separate labeled context; the other labeled context is Ph+ CML-CP after two or more prior tyrosine kinase inhibitors.; Adult Ph+ CML-CP after two or more prior TKIs; adult Ph+ CML-CP with T315I mutation. · The label does not establish reimbursement or routine availability. Mutation testing and prior-TKI history are central to whether the labeled context is relevant. Confidence/conflicts: High for Thai NDI-hosted label indication; payer/procurement remains unverified. No conflict recorded.
  • Azacitidine (Andason / azacitidine for injection)[99]ApprovedNot mutation-restricted in fetched label text; higher-risk MDS/CMML/AML blast thresholds are source-stated.; Adult MDS/CMML/AML product-information context; exact risk/blast eligibility should be verified against the current Thai label at point of care. · The fetched source supports Thai regulator-hosted azacitidine product information but the opened section emphasized safety and adult disease populations rather than a concise indication line. Payer status and individual eligibility are not inferred. Confidence/conflicts: Medium for Thai azacitidine MDS/CMML/AML product-information support; exact indication wording should be refreshed from label front matter. Availability/reimbursement outside the approving regulator not established.
  • Azacitidine (Azadual 100)[100]EMA authorisedNot biomarker-restricted in fetched azacitidine source.; Adult AML contexts described in the Thai azacitidine prescribing information, especially transplant-ineligible settings. · This is product information for azacitidine and not a complete AML treatment guideline, reimbursement policy, or venetoclax-combination label. Pediatric AML efficacy is not established in the source's limited pediatric section. Confidence/conflicts: High for Thai label indication text; venetoclax-combination availability remains unverified from Thai primary source in this batch.
  • Blinatumomab (Blincyto)[101]ApprovedCD19-positive disease implied by blinatumomab mechanism and source indication table; Philadelphia chromosome status separated in WHO table as Ph-negative and Ph-positive relapsed/refractory B-precursor ALL; MRD context also listed.; Relapsed/refractory Ph-negative or Ph-positive B-precursor ALL and MRD ALL contexts as listed in the WHO application table for Thailand. · The Thai NDI fetched page verifies Thai product registration but not the indication text in the page body fetched in this cycle. The indication-country mapping comes from a WHO application table and should be checked against Thai-language approved product information before patient-facing reuse. Reimbursement, hospital formulary access, age limits, CD19 testing requirements, and individual eligibility are not established by these sources. Confidence/conflicts: Medium for Thailand-specific indication mapping because WHO provides the indication table and Thai NDI verifies registration, but fetched Thai NDI page did not expose the local indication text; no conflict found.
  • Dasatinib (Dasatinib Teva)[102]ApprovedPhiladelphia chromosome-positive CML; Ph+ ALL and lymphoid blast CML contexts also appear in the fetched label but are not the primary CML cell here.; Newly diagnosed Ph+ CML chronic phase; chronic/accelerated/blast-phase CML after resistance or intolerance to prior therapy including imatinib; pediatric Ph+ CML-CP settings as stated. · Product information does not establish Thai payer status, preauthorization success, hospital formulary access, or individual suitability. Confidence/conflicts: High for Thai NDI-hosted label indication; payer status needs separate access source. No conflict recorded. Availability/reimbursement outside the approving regulator not established.
  • Dasatinib (Dasatinib Teva)[102]ApprovedPhiladelphia chromosome-positive ALL; lymphoid blast CML with resistance or intolerance to prior therapy.; Adult Ph+ ALL or lymphoid blast CML after resistance/intolerance to prior therapy; pediatric newly diagnosed Ph+ ALL in combination with chemotherapy. · Product information does not establish reimbursement or protocol access. Pediatric and adult ALL pathways require disease-specific protocol review and specialist team interpretation. Confidence/conflicts: High for Thai NDI-hosted label indication; payer/protocol details remain gaps. No conflict recorded.
  • Gilteritinib (Xospata)[103]ApprovedFLT3 mutation; positive FLT3 mutation test required by source; Relapsed or refractory AML with FLT3 mutation. · The Thai NDI record is prescribing information and does not establish reimbursement, hospital formulary access, or individual eligibility. The source says prescribing should be by hematology/hemato-oncology specialists and includes safety-monitoring requirements that should not be surfaced as dosing instructions. Confidence/conflicts: High for Thai label indication text; no payer/access claim made.
  • Ibrutinib (Imbruvica), including single-agent and combination contexts named in the prescribing information[104]Approved17p deletion is a separate labeled CLL/SLL indication in the fetched Thai NDI-hosted Imbruvica prescribing information.; Adult CLL/SLL; adult CLL/SLL with 17p deletion; combination contexts as stated in the Thai NDI-hosted prescribing information. · Product information does not establish Thai payer status, hospital formulary access, or which combinations are reimbursed or routinely available. Obinutuzumab access still needs a direct Thai primary-source check. Confidence/conflicts: High for Thai NDI-hosted label indication and combination wording; payer/implementation remains unverified. No conflict recorded.
  • Imatinib (Imatinib Eurodrug)[105]ApprovedPhiladelphia chromosome (bcr-abl) positive / Ph+ CML; Newly diagnosed Ph+ CML when bone marrow transplantation is not first-line; chronic phase after interferon-alpha failure; accelerated phase or blast crisis. · This is a Thai NDI-hosted product SmPC and does not establish reimbursement, current hospital formulary status, or whether imatinib is preferred over other TKIs for a specific patient. It also includes non-CML indications that should not be mixed into this CML finding. Confidence/conflicts: High for Thai product-information indication text; no payer/access claim made.
  • Imatinib mesilate; dasatinib[106]ApprovedPhiladelphia chromosome-positive ALL.; First-line Ph+ ALL with chemotherapy for imatinib; second-line Ph+ ALL with chemotherapy when imatinib cannot be used for dasatinib. · Thai-language national-list/access text requires human review. This is an access-condition row, not an individualized eligibility statement or full treatment protocol. Confidence/conflicts: Medium-high for Thai access-condition signal; human Thai-language review needed and current implementation should be refreshed. No conflict recorded. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team. Availability/reimbursement outside the approving regulator not established.
  • Lenalidomide[107]ApprovedIsolated del(5q) cytogenetic abnormality; low- or intermediate-1-risk MDS.; Adult low- or intermediate-1-risk del(5q) MDS with transfusion-dependent anemia when other options are insufficient/inadequate. · Product information does not establish payer coverage, current cytogenetic testing access, pregnancy-prevention controls, or individual suitability. Confidence/conflicts: High for Thai label indication text; payer and diagnostic access remain gaps. Availability/reimbursement outside the approving regulator not established.
  • Luspatercept (Reblozyl)[108]ApprovedRing sideroblasts; very low, low, or intermediate risk; erythropoietin-based therapy unsatisfactory response or ineligibility.; Adult transfusion-dependent anemia due to lower-risk MDS with ring sideroblasts after ESA unsatisfactory response or ESA ineligibility. · Product information does not establish Thai payer status, hospital formulary access, transfusion thresholds, or whether a patient meets MDS risk and ring-sideroblast criteria. Confidence/conflicts: High for Thai NDI-hosted indication text; payer/implementation remains unverified. No conflict recorded. Availability/reimbursement outside the approving regulator not established.
  • Nilotinib (Tasigna)[109]ApprovedPh+ CML; resistance/intolerance context includes prior imatinib.; Newly diagnosed Ph+ CML chronic phase in adults and pediatrics; resistant/intolerant Ph+ CML chronic phase in pediatrics; resistant/intolerant adult chronic or accelerated phase. · The source is product information, not a treatment-ranking guideline. It includes monitoring and safety requirements; the queue records indication/settings only and avoids dosing. Reimbursement and center access in Thailand remain unverified. Confidence/conflicts: High for Thai product-information indications; no comparative or reimbursement claim made.
  • Rituximab (Ruxience) with systemic chemotherapy[110]ApprovedCD20-positive pediatric B-cell NHL context.; Previously untreated advanced-stage CD20-positive pediatric BL/BAL/BLL, age 6 months to under 18 years. · The product information supports a pediatric Burkitt/Burkitt leukemia/Burkitt-like label context but does not establish Thai payer coverage, ThaiPOG protocol details, hospital capability, or individual eligibility. Confidence/conflicts: High for Thai product-information indication text; payer and protocol details remain gaps. Availability/reimbursement outside the approving regulator not established.
  • Ruxolitinib (Jakavi)[111]ApprovedRisk category high or intermediate risk; no specific mutation restriction in fetched Thai label indication.; High- or intermediate-risk myelofibrosis with disease-related splenomegaly or symptoms. · Product information does not establish Thai reimbursement, hospital formulary access, or suitability for an individual patient. Confidence/conflicts: High for Thai label indication text; payer and sequencing remain gaps.
  • Tyrosine kinase inhibitor access controls for imatinib, nilotinib and dasatinib[112]ApprovedCML diagnosis; specific cytogenetic/molecular monitoring criteria are described in Thai controlled-use documents but need human Thai-language review before patient-facing reuse.; CML TKI access-control pathway for imatinib, nilotinib and dasatinib. · Thai-language access criteria require human review. This row is an access-process signal only; it does not establish that every patient can obtain a listed medicine or that asciminib/ponatinib are covered. Confidence/conflicts: Medium-high for access-process existence; Thai-language human review required and individual payer implementation remains unverified. No conflict recorded. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team. Availability/reimbursement outside the approving regulator not established.
  • Venetoclax (Venclexta)[113]Approved17p deletion or TP53 mutation in one indication; absence of 17p deletion/TP53 mutation in another post-treatment indication.; Previously treated adult CLL settings defined by 17p/TP53 status and prior B-cell receptor pathway inhibitor and/or chemoimmunotherapy failure. · This Thai NDI source supports venetoclax monotherapy indications only in the fetched text; it does not establish Thailand reimbursement, combination use with anti-CD20 therapy, tumor-lysis monitoring access, or individual eligibility. Confidence/conflicts: High for Thai product-information indication text; modern combination-label and payer status remain gaps.
  • Zanubrutinib (Brukinsa)[114]ApprovedNo mutation restriction stated in the fetched Thai NDI-hosted Brukinsa package insert indication.; Adult CLL/SLL, as stated in the Thai NDI-hosted package insert. · The package insert does not establish reimbursement, hospital formulary placement, sequencing versus other BTK inhibitors, or individual suitability. Confidence/conflicts: High for Thai NDI-hosted indication text; payer/sequence details remain unverified. No conflict recorded.
  • blinatumomab (Blincyto)[115]FDA-approvedCD19-positive B-cell precursor ALL context from international Blincyto label; Thai NDI source confirms product registration but does not provide English indication text in the fetched snippet; Thai Blincyto registered-product signal for ALL-related option mapping; exact Thai ALL indication/line remains source-pending. · The source is Thai-language regulator/NDI content and needs human review. Do not infer reimbursement, National List status, hospital availability, or exact ALL indication from the registration listing alone. Confidence/conflicts: Medium-high for Thai product registration; low for exact indication because the fetched Thai source did not provide English indication text. No conflict identified. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • blinatumomab (Blincyto) access verification; package-information and National List/formulary check[101]EMA authorisedCD19/MRD or relapsed-refractory context must be confirmed from Thai label or treating center; Thai ALL access planning after product-registration confirmation. · A registration number is not equivalent to reimbursement or actual hospital access. Exact Thai clinical indication and access criteria require product-information and payer/formulary verification. Confidence/conflicts: Medium for Thai access planning because registration is verified but payer/formulary status remains unverified. No conflict identified. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • bosutinib (Bosulif)[116]Standard option (per PubMed / International Journal of Hematology)Philadelphia chromosome-positive / BCR::ABL1-positive CML; First-line CML-CP option signal in Thailand-authored real-world literature; Asian first-line clinical-trial evidence context. · Direct Thai FDA Bosulif/bosutinib registration and payer status were not fetched; MIMS Thailand was search-visible but blocked by 403 on fetch. Treat this as a country availability/evidence signal requiring Thai FDA and hospital formulary confirmation. Confidence/conflicts: Medium for Thailand bosutinib availability/evidence signal; low for formal Thai regulatory and reimbursement status until direct Thai FDA data are fetched. No conflict identified.
  • imatinib mesylate (Imatinib Eurodrug)[105]ApprovedPhiladelphia chromosome / bcr-abl positive CML; Pediatric newly diagnosed Ph+ CML when transplant is not first-line; pediatric chronic phase after interferon-alpha failure; pediatric accelerated phase or blast crisis. · This is label-backed indication scope only. The SmPC does not establish Thai payer status, hospital formulary access, or that imatinib is preferred over other TKIs in a specific pediatric case. Confidence/conflicts: High for Thai NDI-hosted pediatric imatinib indication scope; payer/access remains unverified. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • ponatinib (Iclusig)[117]FDA-approvedBCR::ABL1-positive CML; T315I and resistance/intolerance contexts are relevant in the label evidence base; The Thai NDI product detail verifies registered ponatinib product availability; detailed CML line/phase wording is taken from the linked Iclusig physician information rather than the registration page itself. · Thai NDI registration does not establish individual access, reimbursement, hospital formulary status, or suitability. The product-detail page is Thai-language; clinical interpretation should be checked against the physician label and local hematology team. Confidence/conflicts: High for Thai registration of Iclusig 15 mg; medium for current access/reimbursement because payer details were not verified. No conflict identified.
  • ponatinib (Iclusig)[118]ApprovedBCR::ABL1-positive CML; T315I mutation and resistance/intolerance to dasatinib or nilotinib appear in the label's clinical-study cohorts; Specialist-managed ponatinib context for CML patients represented in CP-CML, AP-CML, and BP-CML resistant/intolerant or T315I cohorts. · This catalog entry does not provide dosing or risk management instructions. The label stresses specialist initiation and monitoring; Thailand reimbursement and hospital procurement were not verified. Confidence/conflicts: Medium-high for Thai label evidence context; current label version and payer access need local confirmation. No conflict identified.
  • rituximab (Ruxience)[110]FDA-approvedCD20-positive; Pediatric, previously untreated advanced-stage CD20-positive mature B-cell lymphoma/Burkitt spectrum. · The fetched Thai product information supports pediatric Burkitt-spectrum labeling, not adult Burkitt use. Payer criteria, hospital procurement, and ThaiPOG protocol implementation require separate confirmation. Confidence/conflicts: High for Thailand pediatric Ruxience label wording; adult Burkitt remains unverified. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • rituximab with ThaiPOG Mature B-cell lymphoma protocol chemotherapy[119]ApprovedCD20-positive rituximab use context; Pediatric mature B-cell lymphoma first-line controlled-use pathway; Thai-language source requires human review. · This source is Thai-language controlled-use criteria and must be human-reviewed before patient-facing reuse. It supports a pediatric protocol-access framework, not adult Burkitt coverage. Confidence/conflicts: Medium-high for Thailand controlled-use framework; Thai-language human review needed and adult Burkitt payer status remains a gap. No conflict identified. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team. Availability/reimbursement outside the approving regulator not established.

Canada

  • CODOX-M with rituximab as LYCODOXMR, usually before IVACR as part of Magrath protocol[120]Approvedhigh-risk features include stage IV, bulk at least 5 cm, or LDH above normal; double-hit cytogenetics included in protocol eligibility; Newly diagnosed Burkitt lymphoma/leukemia protocol; low-risk and high-risk sequencing with IVACR described by BC Cancer. · This is a British Columbia protocol and reimbursement statement, not a Canada-wide rule. It includes renal/hepatic exclusions, mandatory tests, methotrexate monitoring, inpatient/supportive-care requirements, and clinician-judgment warnings. Confidence/conflicts: High for British Columbia protocol and reimbursement wording; not generalizable to all Canadian provinces. No conflict identified.
  • Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel), Besponsa (inotuzumab ozogamicin), blinatumomab (Blincyto), transplant evaluation[121]Health Canada approvedCD19-positive CAR-T contexts; CD22-positive inotuzumab context; B-cell precursor ALL; Relapsed/refractory B-cell ALL option-mapping and transplant/CAR-T/immunotherapy sequencing discussion. · This is a catalog map, not a treatment sequence. Availability, eligibility, bridging therapy, manufacturing time, transplant candidacy, and provincial funding must be checked locally. Confidence/conflicts: High for option-map existence by product indication; sequencing remains an open clinical/protocol question. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • all-trans retinoic acid (ATRA; tretinoin); arsenic trioxide (ATO); chemotherapy when used with differentiation therapy[122]Standard option (per Canadian Cancer Society)APL subtype; source lists differentiation therapy context; Childhood APL initial treatment and relapsed APL after ATRA context. · The source does not give pediatric regimen details, provincial funding, or Health Canada pediatric product-label details for ATRA/ATO. Confidence/conflicts: Medium-high for pediatric APL options; product-label and protocol detail remain gaps. No conflict identified.
  • all-trans retinoic acid (ATRA; tretinoin); arsenic trioxide (ATO; Trisenox and generics); idarubicin; daunorubicin (Cerubidine); cytarabine; gemtuzumab ozogamicin (Mylotarg)[123]Standard option (per Alberta Health Services Guideline Resource Unit)PML-RARA / t(15;17) confirmation context; low/intermediate versus high-risk APL by white blood cell count; Newly diagnosed APL induction and consolidation; risk-adapted low/intermediate-risk and high-risk APL. · This is Canada/Alberta guideline and Canadian cancer-information content, not individualized protocol selection. Drug availability and funding vary by province and regimen. Confidence/conflicts: High for Canadian APL induction/consolidation framework. No conflict identified.
  • arsenic trioxide (Trisenox and generics); tretinoin / all-trans retinoic acid (ATRA)[124]ApprovedAPL; low- to intermediate-risk APL regimen context; Ontario adult low/intermediate-risk APL induction, first-line or relapsed/refractory setting; arsenic trioxide funding also listed for consolidation. · Ontario formulary and regimen pages are provider information and do not apply to all patients or all provinces. The regimen abstract is abbreviated and intended for adult leukemia centers with acute leukemia expertise. Confidence/conflicts: High for Ontario funding/regimen signal; medium for direct extrapolation beyond Ontario. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • blinatumomab (Blincyto)[125]EMA authorisedPhiladelphia chromosome-negative; CD19-positive; MRD at least 0.1%; adult and pediatric relapsed/refractory contexts; Consolidation phase of multiphase chemotherapy, MRD-positive remission, adult relapsed/refractory B-cell precursor ALL, and pediatric Ph-negative relapsed/refractory B-cell precursor ALL. · Product-monograph indications do not establish provincial funding, center availability, or individual eligibility. MRD testing must use an accredited laboratory with validated assay methods per the product monograph. Confidence/conflicts: High for Canadian blinatumomab indications. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • blinatumomab (Blincyto)[126]Health Canada approvedCD19-positive B-cell precursor ALL; MRD-positive and consolidation/relapsed contexts depending on regimen; Ontario ALL blinatumomab formulary/regimen support, with indication details deferred to the product monograph and specific CCO regimens. · Ontario formulary and regimen pages are not national reimbursement rules and do not apply to every patient. Funding and treatment details require regimen-specific criteria. Confidence/conflicts: High for Ontario formulary signal; medium for funding applicability because CCO explicitly warns it may not apply to all patients. No conflict identified.
  • brexucabtagene autoleucel (Tecartus)[127]Health Canada approvedB-cell precursor ALL; adult indication; CD19-directed CAR-T product; Adult relapsed or refractory B-cell precursor ALL in Canada. · Product-monograph approval is not the same as provincial funding or immediate treatment-center availability. Pediatric use is not Health Canada-authorized per the source. Confidence/conflicts: High for Canadian adult R/R B-cell precursor ALL indication and no pediatric authorization. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • chemotherapy with daunorubicin, idarubicin, or mitoxantrone; arsenic trioxide (ATO) with or without ATRA; ATO plus ATRA plus chemotherapy or gemtuzumab ozogamicin; stem cell transplant after second remission[128]Standard option (per Canadian Cancer Society)Prior treatment history, remission duration, PML-RARA monitoring context; Relapsed or refractory APL; post-second-remission transplant consideration. · Transplant consideration depends on remission status and specialist assessment. Ontario arsenic trioxide funding signals are province- and criteria-specific. Confidence/conflicts: High for relapsed/refractory APL options and Ontario arsenic trioxide funding categories. No conflict identified.
  • chemotherapy; radiation therapy; targeted therapy including tyrosine kinase inhibitor for Philadelphia chromosome-positive ALL; stem cell transplant; supportive therapy[129]Standard option (per Canadian Cancer Society)Philadelphia chromosome status; CNS involvement; response/MRD context; relapse/refractory context; Adult ALL initial treatment phases, CNS prophylaxis/treatment, Ph-positive ALL targeted therapy with chemotherapy, and relapsed/refractory ALL. · Canadian Cancer Society and Cancer Care Ontario patient education are not individualized protocols, drug labels, or funding guarantees. Confidence/conflicts: High for broad Canadian ALL treatment categories. No conflict identified.
  • gilteritinib (Xospata)[130]Health Canada approvedFLT3 mutation; validated test required; Adult relapsed or refractory FLT3-mutated AML. · Ontario funding signals are criteria-based and province-specific. This entry does not establish pediatric use or first-line use in Canada. Confidence/conflicts: High for Health Canada adult R/R FLT3-mutated AML authorization and Ontario funding signal. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • induction chemotherapy; consolidation chemotherapy; intrathecal chemotherapy for CNS treatment or prevention[122]Standard option (per Canadian Cancer Society)AML risk group; CNS involvement; treatment response; age and overall health factors; Newly diagnosed childhood AML induction, consolidation/post-remission, and CNS treatment/prevention. · The source is Canadian childhood leukemia treatment information, not a protocol-specific dosing guide or individual eligibility rule. Confidence/conflicts: High for broad Canadian childhood AML chemotherapy phases. No conflict identified.
  • induction chemotherapy; consolidation chemotherapy; maintenance chemotherapy; targeted therapy for selected mutations; stem cell transplant; radiation therapy; supportive therapy[131]Established standard of careAML subtype, chromosome changes, genetic mutations, CNS spread, age, prior chemotherapy, prior MDS, white blood cell count; Newly diagnosed AML treatment planning, induction, consolidation/post-remission, maintenance for selected patients, relapsed/refractory AML, radiation/supportive care contexts. · This is Canadian cancer-information content, not a provincial protocol, individual eligibility rule, or drug funding rule. Confidence/conflicts: High for broad Canadian AML treatment categories. No conflict identified.
  • inotuzumab ozogamicin (Besponsa)[132]Health Canada approvedCD22-positive B-cell precursor ALL; Adult relapsed or refractory CD22-positive B-cell precursor ALL. · This entry uses CADTH/CCO and product monograph sources rather than a direct Health Canada RDS. Provincial funding and individual eligibility require local criteria. Confidence/conflicts: Medium-high for Canadian adult R/R CD22-positive B-cell precursor ALL indication; direct Health Canada decision page remains useful to add later. No conflict identified.
  • luspatercept (Reblozyl)[133]Approvedring sideroblasts; failed or unsuitable for erythropoietin-based therapy; Adult very low- to intermediate-risk MDS with ring sideroblasts and RBC transfusion-dependent anemia after ESA failure or ESA unsuitability. · CADTH/CDA-AMC recommendations do not automatically equal coverage in every Canadian province or territory. Provincial formularies, specialist prescribing, renewal criteria, and price conditions need local verification. Confidence/conflicts: High for CADTH/CDA-AMC reimbursement recommendation terms; provincial implementation remains a gap. No conflict identified.
  • quizartinib (Vanflyta)[134]Health Canada approvedFLT3-ITD positive AML; clinical-trial population adult patients aged 20 to 75 in QuANTUM-First; Evidence basis for adult newly diagnosed FLT3-ITD-positive AML approval. · The clinical-trial description is evidence context for approval, not a currently recruiting trial listing or patient eligibility statement. Confidence/conflicts: High for evidence-basis and Project Orbis/regulatory process details. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • quizartinib (Vanflyta) marketed tablets; risk-management plan, health professional guide, patient card, ECG/electrolyte monitoring context[135]Health Canada approvedFLT3-ITD positive AML; QT interval risk context; Canadian marketed product and safety-supportive monitoring context for approved AML use. · DIN/marketed status is not the same as reimbursement or local stock availability. Safety-monitoring details should come from the product monograph and oncology team. Confidence/conflicts: High for Canadian marketed product record and Health Canada risk caveats. No conflict identified.
  • quizartinib (Vanflyta) with standard cytarabine and anthracycline induction, standard cytarabine consolidation, followed by quizartinib maintenance monotherapy[134]Health Canada approvedFLT3-ITD positive AML; validated test required to confirm FLT3-ITD status; Adult newly diagnosed FLT3-ITD-positive AML with induction, consolidation, and maintenance after consolidation as specified by Health Canada. · Health Canada states improvement in overall survival has not been demonstrated for maintenance monotherapy following allogeneic hematopoietic stem cell transplantation. This does not establish provincial reimbursement or individual eligibility. Confidence/conflicts: High for Canadian authorization and indication boundaries. No conflict identified.
  • reinduction chemotherapy; stem cell transplant; targeted therapy; immunotherapy; radiation therapy[136]Standard option (per Canadian Cancer Society)Site of relapse including CNS or extramedullary relapse; high-risk relapse; targetable disease context; Recurrent or refractory childhood ALL in Canada. · This is Canadian childhood leukemia information, not an individual protocol or provincial funding pathway. Specific immunotherapy/targeted options require disease markers and product-label or trial review. Confidence/conflicts: High for Canadian recurrent childhood ALL treatment categories. No conflict identified.
  • stem cell transplant; radiation therapy for selected CNS/testicular/HSCT preparation contexts[122]Standard option (per Canadian Cancer Society)High-risk or recurrent disease context; donor availability and transplant suitability; High-risk childhood AML, recurrent AML, CNS/testicular disease contexts, and transplant preparation. · Stem cell transplant and radiation depend on disease risk, response, donor match, organ function, and specialist center review. Radiation is described as sometimes used, not routine for every child. Confidence/conflicts: High for Canadian childhood AML transplant/radiation contexts. No conflict identified.
  • supportive therapy; antibiotics and antifungals; growth factors; transfusions; clinical trials[122]Standard option (per Canadian Cancer Society)Treatment complications and infection/cytopenia risk context; Support during chemotherapy or transplant pathways; clinical-trial discussion at treatment decision points. · Clinical-trial availability varies by center, date, age, disease subtype, and eligibility criteria. Supportive measures are treatment-team managed. Confidence/conflicts: High for Canadian supportive and trial-discussion framing. No conflict identified.
  • tisagenlecleucel (Kymriah)[121]Health Canada approvedCD19-positive B-cell ALL implied by CD19-directed CAR-T; pediatric and young adult age up to and including 25 years; Pediatric and young adult relapsed/refractory B-cell ALL up to and including age 25, including refractory disease, relapse after allo-SCT, SCT-ineligible status, or second/later relapse. · CAR-T access requires specialized qualified centers, manufacturing, fitness, and funding pathways. The product monograph indication does not guarantee availability in every province or center. Confidence/conflicts: High for Canadian Kymriah ALL indication. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • urgent ATRA initiation when APL suspected; blood product support; antibiotics/antifungals; growth factors; transfusions; steroids for suspected differentiation syndrome; monitoring during arsenic trioxide therapy[123]Standard option (per Alberta Health Services Guideline Resource Unit)Coagulopathy/DIC, differentiation syndrome, QTc prolongation, liver toxicity, tumor lysis risk; Suspected APL at presentation, induction with ATRA/ATO, coagulopathy/differentiation-syndrome management, and relapsed/refractory supportive care. · Supportive interventions are treatment-team decisions and may be urgent; they are cataloged as options to discuss, not self-management steps. Confidence/conflicts: High for supportive-care urgency and monitoring framework. No conflict identified.
  • venetoclax (Venclexta) in combination with azacitidine; venetoclax (Venclexta) in combination with low-dose cytarabine[137]Health Canada approvedNot biomarker-specific; age 75 years or older or comorbidities precluding intensive induction chemotherapy; Newly diagnosed AML in older adults or patients with comorbidities precluding intensive induction chemotherapy; Ontario public funding signals for venetoclax plus azacitidine based on criteria. · Ontario funding entries do not establish access in all Canadian provinces or individual eligibility. The product monograph records venetoclax plus azacitidine or low-dose cytarabine; Ontario funding text specifically names venetoclax plus azacitidine for previously untreated AML. Confidence/conflicts: High for Canadian indication and Ontario funding signal. No conflict identified. Availability/reimbursement outside the approving regulator not established.

출처

  1. FDA — approval notice (venetoclax combination, AML) · FDA regulator approval notice
  2. FDA — approval notice (revumenib, KMT2A-translocated acute leukemia) · FDA regulator approval notice
  3. EMA EPAR — Xospata (gilteritinib) · EMA EPAR
  4. NICE TA1013 · NICE health technology appraisal
  5. FDA — approval notice (blinatumomab consolidation, B-cell ALL) · FDA regulator approval notice
  6. EMA EPAR — Kymriah (tisagenlecleucel) · EMA EPAR
  7. NICE TA975 · NICE health technology appraisal
  8. NCI PDQ — Adult Acute Lymphoblastic Leukemia Treatment · NCI PDQ
  9. FDA — accelerated approval notice (asciminib, newly diagnosed CML) · FDA regulator accelerated approval notice
  10. EMA EPAR — Scemblix (asciminib) · EMA EPAR
  11. NICE TA813 · NICE health technology appraisal
  12. NCI PDQ — Chronic Myelogenous Leukemia Treatment · NCI PDQ
  13. FDA — approval notice (acalabrutinib + venetoclax, CLL/SLL) · FDA regulator approval notice
  14. EMA EPAR — Calquence (acalabrutinib) · EMA EPAR
  15. NICE TA1119 · NICE health technology appraisal
  16. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  17. National Cancer Institute (NCI) — national cancer agency patient evidence summary · national cancer agency patient evidence summary
  18. U.S. Food and Drug Administration (FDA) — regulator drug trial snapshot · regulator drug trial snapshot
  19. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  20. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  21. National Cancer Institute (NCI) — national cancer agency FDA-approval news/update · national cancer agency FDA-approval news/update
  22. U.S. Food and Drug Administration (FDA) — FDA approval notification for pediatric bosutinib in CML · FDA approval notification for pediatric bosutinib in CML
  23. National Cancer Institute (NCI) PDQ Pediatric Treatment Editorial Board — NCI PDQ health-professional summary for childhood CML treatment · NCI PDQ health-professional summary for childhood CML treatment
  24. DailyMed / U.S. National Library of Medicine — official drug label · official drug label
  25. U.S. Food and Drug Administration (FDA) — FDA cellular and gene therapy product page for Breyanzi/lisocabtagene maraleucel · FDA cellular and gene therapy product page for Breyanzi/lisocabtagene maraleucel
  26. U.S. Food and Drug Administration (FDA) — FDA traditional approval notice for pirtobrutinib in CLL/SLL · FDA traditional approval notice for pirtobrutinib in CLL/SLL
  27. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  28. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  29. Haute Autorite de Sante (HAS) — France HAS transparency/clinical added value page · France HAS transparency/clinical added value page
  30. European Medicines Agency (EMA) — regulator EPAR withdrawn authorization page · regulator EPAR withdrawn authorization page
  31. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  32. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  33. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  34. Institute for Quality and Efficiency in Health Care (IQWiG) — German benefit assessment project page for acalabrutinib combination in untreated CLL · German benefit assessment project page for acalabrutinib combination in untreated CLL
  35. Haute Autorite de Sante (HAS) — France HAS CML care-pathway context in asciminib opinion · France HAS CML care-pathway context in asciminib opinion
  36. Gemeinsamer Bundesausschuss (G-BA) — German HTA resolution courtesy translation for asciminib in CML · German HTA resolution courtesy translation for asciminib in CML
  37. Gemeinsamer Bundesausschuss (G-BA) — German G-BA justification courtesy translation for blinatumomab adult consolidation ALL · German G-BA justification courtesy translation for blinatumomab adult consolidation ALL
  38. Gemeinsamer Bundesausschuss (G-BA) — German G-BA justification courtesy translation for pediatric blinatumomab ALL · German G-BA justification courtesy translation for pediatric blinatumomab ALL
  39. Haute Autorite de Sante (HAS) — France HAS reimbursement opinion page for Blincyto/blinatumomab · France HAS reimbursement opinion page for Blincyto/blinatumomab
  40. European Medicines Agency (EMA) — EMA EPAR webpage for Bosulif/bosutinib · EMA EPAR webpage for Bosulif/bosutinib
  41. European Medicines Agency (EMA) — EMA EPAR webpage for Tecartus · EMA EPAR webpage for Tecartus
  42. Gemeinsamer Bundesausschuss (G-BA) — German G-BA justification courtesy translation for brexucabtagene autoleucel · German G-BA justification courtesy translation for brexucabtagene autoleucel
  43. European Medicines Agency (EMA) — EMA EPAR webpage for Besponsa · EMA EPAR webpage for Besponsa
  44. Haute Autorite de Sante (HAS) — France HAS reassessment page for Besponsa/inotuzumab ozogamicin · France HAS reassessment page for Besponsa/inotuzumab ozogamicin
  45. Gemeinsamer Bundesausschuss (G-BA) — Germany G-BA current-version resolution courtesy translation for luspatercept in MDS anemia · Germany G-BA current-version resolution courtesy translation for luspatercept in MDS anemia
  46. Gemeinsamer Bundesausschuss (G-BA) — Germany G-BA resolution courtesy translation for luspatercept in ring-sideroblast MDS anemia · Germany G-BA resolution courtesy translation for luspatercept in ring-sideroblast MDS anemia
  47. Haute Autorite de Sante (HAS) — France HAS reimbursement opinion page for Reblozyl in MDS · France HAS reimbursement opinion page for Reblozyl in MDS
  48. European Medicines Agency (EMA) — EMA EPAR webpage for Jaypirca/pirtobrutinib · EMA EPAR webpage for Jaypirca/pirtobrutinib
  49. Institute for Quality and Efficiency in Health Care (IQWiG) — German benefit assessment project page for pirtobrutinib in CLL · German benefit assessment project page for pirtobrutinib in CLL
  50. Haute Autorite de Sante (HAS) — France HAS reimbursement/clinical added value page for ponatinib · France HAS reimbursement/clinical added value page for ponatinib
  51. Haute Autorite de Sante (HAS) — France HAS Transparency Committee summary for MabThera extension in pediatric mature B-cell NHL/Burkitt spectrum · France HAS Transparency Committee summary for MabThera extension in pediatric mature B-cell NHL/Burkitt spectrum
  52. Gemeinsamer Bundesausschuss (G-BA) — German G-BA current-version resolution courtesy translation · German G-BA current-version resolution courtesy translation
  53. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance PDF · technology appraisal guidance PDF
  54. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  55. Oxford NSSG Haematology / NHS — NHS chemotherapy protocol · NHS chemotherapy protocol
  56. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  57. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  58. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  59. National Institute for Health and Care Excellence (NICE) — NICE technology appraisal guidance TA893 · NICE technology appraisal guidance TA893
  60. National Institute for Health and Care Excellence (NICE) — NICE technology appraisal guidance TA541 · NICE technology appraisal guidance TA541
  61. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator approved-drug list · regulator approved-drug list
  62. Pharmaceuticals and Medical Devices Agency (PMDA) — English PMDA review report for Kymriah/tisagenlecleucel · English PMDA review report for Kymriah/tisagenlecleucel
  63. CancerNetwork — Specialty oncology news summary of Japan acalabrutinib approval · Specialty oncology news summary of Japan acalabrutinib approval
  64. Nippon Shinyaku — Company announcement reporting Japan MHLW marketing authorization for Vidaza in MDS · Company announcement reporting Japan MHLW marketing authorization for Vidaza in MDS
  65. Amgen — Company press release reporting Japan MHLW approval · Company press release reporting Japan MHLW approval
  66. Pharmaceuticals and Medical Devices Agency (PMDA) — Japanese PMDA deliberation-results report for Besponsa/inotuzumab ozogamicin · Japanese PMDA deliberation-results report for Besponsa/inotuzumab ozogamicin
  67. PMC / Japanese real-world lower-risk MDS treatment-patterns article — Peer-reviewed article noting Japan approval of luspatercept in lower-risk MDS anemia · Peer-reviewed article noting Japan approval of luspatercept in lower-risk MDS anemia
  68. Pharmaceuticals and Medical Devices Agency (PMDA) — Japan PMDA English review report for rasburicase in leukemia/malignant lymphoma tumor-lysis contexts · Japan PMDA English review report for rasburicase in leukemia/malignant lymphoma tumor-lysis contexts
  69. Health Insurance Review and Assessment Service (HIRA) — Korea reimbursement review committee press release · Korea reimbursement review committee press release
  70. The Korean Journal of Internal Medicine — Peer-reviewed Korean multicenter retrospective CLL/SLL treatment-pattern study · Peer-reviewed Korean multicenter retrospective CLL/SLL treatment-pattern study
  71. Korean Journal of Medicine / Korean Society of Hematology CML Working Party — Korean CML treatment guideline article · Korean CML treatment guideline article
  72. Korea Biomedical Review — Korean medical trade news reporting MFDS marketing approval · Korean medical trade news reporting MFDS marketing approval
  73. Therapeutic Advances in Hematology / PubMed Central — Peer-reviewed review on radotinib in CML · Peer-reviewed review on radotinib in CML
  74. Korea Pharmaceutical Information Center / reimbursement review materials — Korea review material PDF for Kymriah/tisagenlecleucel · Korea review material PDF for Kymriah/tisagenlecleucel
  75. eviQ / Cancer Institute NSW — Australian clinical resource for antifungal prophylaxis in immunocompromised adults · Australian clinical resource for antifungal prophylaxis in immunocompromised adults
  76. eviQ / Cancer Institute NSW — Australian eviQ protocol for MDS azacitidine · Australian eviQ protocol for MDS azacitidine
  77. Astellas Pharma — Company press release reporting China NMPA conditional approval · Company press release reporting China NMPA conditional approval
  78. Novartis — Company press release with global/China asciminib approval signal · Company press release with global/China asciminib approval signal
  79. FirstWord Pharma — Pharma news summary reporting BeiGene/NMPA approval of Blincyto in China · Pharma news summary reporting BeiGene/NMPA approval of Blincyto in China
  80. Lymphoblastic Hub — Specialty medical news summary reporting China NMPA conditional approval · Specialty medical news summary reporting China NMPA conditional approval
  81. Haematologica — Peer-reviewed real-world flumatinib study with China NMPA approval context · Peer-reviewed real-world flumatinib study with China NMPA approval context
  82. Blood Cancers Today — Specialty hematology news reporting China NMPA market approval · Specialty hematology news reporting China NMPA market approval
  83. Lymphoma Hub — Specialty hematology news summary of China NMPA lisaftoclax approval · Specialty hematology news summary of China NMPA lisaftoclax approval
  84. Innovent Biologics / PRNewswire — Company-distributed announcement of China NMPA approval for pirtobrutinib in CLL/SLL · Company-distributed announcement of China NMPA approval for pirtobrutinib in CLL/SLL
  85. OncLive — Specialty oncology news report of China NMPA zanubrutinib approval expansion · Specialty oncology news report of China NMPA zanubrutinib approval expansion
  86. MedElement clinical recommendations portal / Russian MDS/MDS-MPN clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
  87. MedElement clinical recommendations portal / Russian adult ALL clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
  88. MedElement clinical recommendations portal / Russian CML clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
  89. MedElement clinical recommendations portal / Russian CLL/SLL clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
  90. LegalActs mirror of Russian Ministry of Health clinical recommendations — Russia 2024 pediatric ALL clinical recommendations · Russia 2024 pediatric ALL clinical recommendations
  91. MedElement clinical recommendations portal / Russian HCL clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
  92. MedElement clinical recommendations portal / Russian AML clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
  93. MedElement clinical recommendations portal / Russian Ph-negative MPN clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
  94. Medvestnik clinical recommendations mirror — Russian clinical-recommendation page for CML · Russian clinical-recommendation page for CML
  95. MedElement mirror of Russian Federation clinical recommendations — Russia 2024 adult ALL clinical recommendations · Russia 2024 adult ALL clinical recommendations
  96. VOOG Sodeystvie CML patient organization — Russian CML patient booklet with registered/available TKI list · Russian CML patient booklet with registered/available TKI list
  97. Thai National Drug Information / Thai FDA-MOPH — SmPC PDF / regulator drug-information repository · SmPC PDF / regulator drug-information repository
  98. Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
  99. Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
  100. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  101. Thai National Drug Information / Thai FDA-MOPH — regulator drug-registration page · regulator drug-registration page
  102. Thai National Drug Information / Thai FDA-MOPH — SmPC PDF / regulator drug-information repository · SmPC PDF / regulator drug-information repository
  103. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  104. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  105. Thai National Drug Information / Thai FDA-MOPH — SmPC PDF / regulator drug-information repository · SmPC PDF / regulator drug-information repository
  106. Thai National Drug Information / Thai FDA-MOPH — national medicines list update / controlled-use access notice PDF · national medicines list update / controlled-use access notice PDF
  107. Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
  108. Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
  109. Thai National Drug Information / Thai FDA-MOPH — package information PDF / regulator drug-information repository · package information PDF / regulator drug-information repository
  110. Thai National Drug Information / Thai FDA-MOPH — local product information PDF / regulator drug-information repository · local product information PDF / regulator drug-information repository
  111. Thai National Drug Information / Thai FDA-MOPH — national package leaflet PDF / regulator drug-information repository · national package leaflet PDF / regulator drug-information repository
  112. Thai National Drug Information / Thai FDA-MOPH — controlled-use criteria PDF / national medicines access policy · controlled-use criteria PDF / national medicines access policy
  113. Thai National Drug Information / Thai FDA-MOPH — SmPC PDF / regulator drug-information repository · SmPC PDF / regulator drug-information repository
  114. Thai National Drug Information / Thai FDA-MOPH — package insert PDF / regulator drug-information repository · package insert PDF / regulator drug-information repository
  115. Thai FDA / National Drug Information — Thai NDI drug search result listing · Thai NDI drug search result listing
  116. PubMed / International Journal of Hematology — PubMed abstract for Asian BFORE bosutinib analysis including Bangkok site · PubMed abstract for Asian BFORE bosutinib analysis including Bangkok site
  117. Thai FDA / National Drug Information — Thai registered-product detail page for Iclusig/ponatinib · Thai registered-product detail page for Iclusig/ponatinib
  118. Thai FDA / National Drug Information — Thai NDI-linked Iclusig physician information PDF · Thai NDI-linked Iclusig physician information PDF
  119. Thai FDA / National Drug Information — Thailand controlled-use criteria appendix for essential medicines including rituximab in ThaiPOG mature B-cell lymphoma protocol · Thailand controlled-use criteria appendix for essential medicines including rituximab in ThaiPOG mature B-cell lymphoma protocol
  120. BC Cancer — British Columbia protocol summary for Burkitt lymphoma/leukemia CODOX-M plus rituximab · British Columbia protocol summary for Burkitt lymphoma/leukemia CODOX-M plus rituximab
  121. Novartis Canada / Health Canada product monograph — Canadian product monograph for Kymriah/tisagenlecleucel · Canadian product monograph for Kymriah/tisagenlecleucel
  122. Canadian Cancer Society — Canadian childhood leukemia treatment information · Canadian childhood leukemia treatment information
  123. Alberta Health Services Guideline Resource Unit — Provincial APL clinical practice guideline PDF · Provincial APL clinical practice guideline PDF
  124. Cancer Care Ontario — Ontario arsenic trioxide drug formulary provider monograph · Ontario arsenic trioxide drug formulary provider monograph
  125. Amgen Canada / Health Canada product monograph — Canadian product monograph for blinatumomab · Canadian product monograph for blinatumomab
  126. Cancer Care Ontario — Ontario patient drug information for blinatumomab · Ontario patient drug information for blinatumomab
  127. Gilead Canada / Health Canada product monograph — Canadian product monograph for Tecartus/brexucabtagene autoleucel · Canadian product monograph for Tecartus/brexucabtagene autoleucel
  128. Canadian Cancer Society — Canadian APL treatment information · Canadian APL treatment information
  129. Canadian Cancer Society — Canadian adult ALL treatment information · Canadian adult ALL treatment information
  130. Health Canada Drug and Health Products Portal — Summary Basis of Decision · Summary Basis of Decision
  131. Canadian Cancer Society — Canadian AML treatment information · Canadian AML treatment information
  132. Health Canada / Pfizer product monograph — Canadian product monograph for Besponsa/inotuzumab ozogamicin · Canadian product monograph for Besponsa/inotuzumab ozogamicin
  133. NCBI Bookshelf / CADTH clinical review — Canada CADTH clinical review and reimbursement conditions for luspatercept in MDS · Canada CADTH clinical review and reimbursement conditions for luspatercept in MDS
  134. Health Canada Drug and Health Products Portal — Summary Basis of Decision for Vanflyta/quizartinib · Summary Basis of Decision for Vanflyta/quizartinib
  135. Health Canada Drug and Health Products Portal — Canadian Drug Product Database/DHPP product record · Canadian Drug Product Database/DHPP product record
  136. Canadian Cancer Society — Canadian recurrent/refractory childhood ALL treatment information · Canadian recurrent/refractory childhood ALL treatment information
  137. AbbVie Canada / Health Canada product monograph — Canadian product monograph · Canadian product monograph

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 일부 선택지는 신속·조건부 승인 상태로, 적응증이 축소되거나 철회될 수 있습니다. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026.06.

승인된 치료 너머

임상시험 및 신흥 선택지

환자가 거주하는 국가에서 아직 승인된 표준 치료가 아닌 선택지입니다 — 연구, 임상시험, 허가 외 사용, 담당 종양내과 의사가 먼저 언급하지 않을 수 있는 초기 근거입니다. 각 항목은 근거의 강도에 따라 구분됩니다. 여기에 실린 항목은 조사하고 의료진과 상의할 정보일 뿐, 효과가 입증되었거나 안전하거나 현재 이용 가능하다는 의미가 아닙니다. 임상 세부 내용은 영문이 정본입니다.

임상시험 진행 중

  • venetoclax (Venclexta) + homoharringtonine + cytarabine임상시험 · NCT05805098임상시험In clinical trials (NCT05805098)China · newly diagnosed AML; venetoclax combined with homoharringtonine and cytarabine in induction · Recruiting; single-country (China) study. Investigational regimen, not an approval. ClinicalTrials.gov — NCT05805098
  • CD5-directed CAR T cells임상시험 · NCT06316856임상시험In clinical trials (NCT06316856)China · relapsed or refractory T-cell ALL / T-cell malignancies · Recruiting; single-country (China) study. Investigational cell therapy, not an approval. ClinicalTrials.gov — NCT06316856
  • olverembatinib (TGRX-678)임상시험 · NCT06453902임상시험In clinical trials (NCT06453902)China · chronic-phase and accelerated-phase CML · Recruiting; single-country (China) phase II study. Investigational, not an approval. ClinicalTrials.gov — NCT06453902
  • BGB-16673 (BTK degrader)임상시험 · NCT06846671임상시험In clinical trials (NCT06846671)chronic lymphocytic leukemia; phase III vs investigator's choice · Recruiting; multinational (incl. Korea, Japan, UK, US). Investigational BTK degrader, not an approval. ClinicalTrials.gov — NCT06846671
  • clinical-evaluation options including CAR-T therapy, T-cell engaging bispecific antibodies, non-covalent BTK inhibitors, and allogeneic stem cell transplant consolidation if induction response occurs임상시험임상시험InvestigationalUnited States · DLBCL-type Richter transformation after prior CLL therapies such as chemoimmunotherapy, BTK inhibitors, and/or venetoclax; Poor-prognosis Richter transformation after prior CLL therapy; post-induction response setting for allogeneic transplant consolidation discussion. · Clinical-evaluation options may require trial availability, center eligibility, pathology confirmation, organ function, infection status, and prior therapy review. FDA-approved CAR-T for relapsed/refractory CLL/SLL does not automatically cover all Richter transformation scenarios. Confidence/conflicts: Medium-high for clinical-evaluation framework; indication boundaries and trial availability must be verified case-by-case. No conflict identified. U.S. Food and Drug Administration (FDA) — FDA cellular and gene therapy product page for Breyanzi/lisocabtagene maraleucel
  • pirtobrutinib (Jaypirca)임상시험임상시험InvestigationalEuropean Union · Prior BTK inhibitor and venetoclax exposure; double-refractory subgroup in HAS request; Adult relapsed/refractory CLL after both BTK inhibitor and venetoclax exposure, in the early-access request context. · French-language source; human review needed for legal nuance. Do not interpret the early-access refusal as a final permanent reimbursement decision for every pirtobrutinib CLL scenario. Confidence/conflicts: High for France early-access refusal in stated subgroup; broader reimbursement status remains uncertain. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team. Haute Autorite de Sante (HAS) — France HAS early-access decision page for Jaypirca/pirtobrutinib in CLL
  • Cladribine; dabrafenib plus trametinib임상시험 · NCT02034110임상시험Trial only (NCT02034110)Japan · BRAF V600E for dabrafenib/trametinib rare-cancer basket; no mutation biomarker required in the Japanese cladribine phase II abstract; Japanese patients with HCL in the cladribine phase II paper; BRAF V600E-mutated rare cancers including HCL eligibility context for NCT02034110. · These sources do not establish PMDA approval, reimbursement, current routine access, or individual eligibility. NCT02034110 is completed and was not HCL-only. Confidence/conflicts: Medium-high for country-specific study/trial facts; local approval and access remain unverified. International Journal of Hematology / Springer — peer-reviewed literature abstract
  • Epcoritamab, subcutaneous임상시험 · NCT05206357임상시험Trial only (NCT05206357)Japan · CD20-positive aggressive mature B-cell lymphoma context stated in eligibility; no mutation biomarker stated; Relapsed or primary refractory aggressive mature B-cell neoplasms, including Burkitt or Burkitt-like lymphoma/leukemia; pediatric participants and young adults up to 25 years for Burkitt/Burkitt-like lymphoma/leukemia. · Registry listing does not establish PMDA approval, reimbursement, routine access, active site enrollment, or individual eligibility. The overall trial status is active-not-recruiting, and Japan site-level status was not stated in the fetched location lines. Confidence/conflicts: Medium-high for Japan trial record and Burkitt/Burkitt-like eligibility; no Japan approval claim made. ClinicalTrials.gov — clinical-trial registry
  • Ivosidenib monotherapy; azacitidine monotherapy임상시험 · NCT06465953임상시험Trial only (NCT06465953)Japan · IDH1 R132 mutation required by trial eligibility; HMA-naive MDS with IDH1 R132 mutation; moderate-high/high/very-high IPSS-M risk, and selected lower-risk groups with cytopenias and blasts as described in registry eligibility. · Registry listing does not establish PMDA approval, reimbursement, routine access, or individual eligibility. Some Japan sites are recruiting and one listed Japan site is not-yet-recruiting in the fetched record. Confidence/conflicts: High for registry facts; no approval claim made. ClinicalTrials.gov — clinical-trial registry
  • Pelabresib plus ruxolitinib; fedratinib임상시험 · NCT07340138임상시험Trial only (NCT07340138)Japan · No mutation biomarker required by the fetched records; DIPSS risk category, spleen findings, platelet count, anemia, or prior ruxolitinib context appear in eligibility depending on study; NCT07340138 includes adults already receiving stable ruxolitinib monotherapy who may benefit from adding pelabresib; NCT04446650 includes Japanese participants with DIPSS intermediate-1 with symptoms, intermediate-2, or high-risk MF and measurable splenomegaly. · Registry records do not establish PMDA approval, Japanese reimbursement, routine availability, or individual eligibility. NCT04446650 is active-not-recruiting, not currently recruiting in the fetched registry status. Confidence/conflicts: High for registry status and listed Japan sites; no approval claim made. ClinicalTrials.gov — clinical-trial registry
  • BGB-16673; bendamustine; idelalisib; rituximab; venetoclax; acalabrutinib; PRT2527; zanubrutinib; epcoritamab; venetoclax plus rituximab; bendamustine plus rituximab임상시험 · NCT05006716임상시험Trial only (registry)Korea · Prior exposure to both BTK inhibitor and BCL2 inhibitor for NCT06846671; not mutation-restricted in the cited registry records; Relapsed/refractory or previously treated CLL/SLL, including post-BTK/BCL2 exposure for NCT06846671; untreated and relapsed/refractory CLL safety context for NCT04008706. · Registry records do not establish MFDS approval, reimbursement, standard access, or individual eligibility. Some records are completed or active-not-recruiting; recruiting status must be confirmed with the study site. Confidence/conflicts: High for registry status and location presence; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Blinatumomab-containing reinduction/consolidation/salvage pathways; standard-of-care chemotherapy comparator; stem cell transplantation임상시험 · NCT05827549임상시험Trial only (NCT05827549)Korea · B-precursor context for blinatumomab comparator study; risk-group stratification in relapsed childhood ALL study; Relapsed childhood ALL; relapsed/refractory B-precursor ALL. · Registry trial records do not establish MFDS approval, reimbursement, routine access, or individual eligibility. NCT02013167 is terminated; NCT05827549 is recruiting in fetched registry status. Confidence/conflicts: High for registry status; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Cladribine; dabrafenib plus trametinib임상시험 · NCT02034110임상시험Trial only (NCT02034110)Korea · BRAF V600E for dabrafenib/trametinib rare-cancer basket; no mutation biomarker required in the Korean cladribine study abstract; Korean HCL patients treated with cladribine in the retrospective study; BRAF V600E-mutated rare cancers including HCL eligibility context for NCT02034110. · These sources do not establish MFDS approval, Korean reimbursement, current routine access, or individual eligibility. The ClinicalTrials.gov record is completed and was not HCL-only. Confidence/conflicts: Medium-high for country-specific study/trial facts; local approval and access remain unverified. PubMed / Annals of Hematology — peer-reviewed literature abstract
  • Elritercept with or without ruxolitinib; selinexor, with comparator/local-package-insert context for ruxolitinib, pacritinib, or momelotinib in the trial record임상시험 · NCT05037760임상시험Trial only (NCT05037760)Korea · Anemia criteria for elritercept study; mild or moderate thrombocytopenia and JAK-inhibitor-naive setting for selinexor study; no mutation biomarker required by the fetched records; Adults with MF and anemia for NCT05037760; JAK-inhibitor-naive MF with active symptoms, splenomegaly, and platelet-count criteria for NCT05980806. · Registry entries do not establish MFDS approval, Korean reimbursement, local routine availability, or individual eligibility. Some South Korea sites in NCT05037760 are completed while others are recruiting. Confidence/conflicts: High for registry status and listed South Korea sites; no approval claim made. ClinicalTrials.gov — clinical-trial registry
  • Epcoritamab; sepantronium bromide; rituximab-containing immunochemotherapy observational record임상시험 · NCT05206357임상시험Trial only (registry)Korea · CD20-positive context for epcoritamab trial; c-Myc rearranged high-grade B-cell lymphoma context for sepantronium trial; no single required biomarker across all listed records; Relapsed/refractory aggressive mature B-cell neoplasms; relapsed/refractory c-Myc rearranged high-grade B-cell lymphoma; adult first-line rituximab plus chemotherapy observational context. · Registry records do not establish MFDS approval, reimbursement, routine access, active site enrollment, or individual eligibility. NCT01809600 is observational and completed, not an interventional availability pathway. Confidence/conflicts: High for trial/observational registry facts; low for current clinical availability because records are active-not-recruiting or completed and no regulator approval source was fetched. ClinicalTrials.gov — clinical-trial registry
  • Ivosidenib/AG-120 with azacitidine; gilteritinib versus salvage chemotherapy options including low-dose cytarabine, azacitidine, MEC, and FLAG-IDA임상시험 · NCT03173248임상시험Trial only (NCT03173248)Korea · IDH1 mutation for ivosidenib-azacitidine study; FLT3 mutation for gilteritinib salvage study; Previously untreated IDH1-mutated AML for NCT03173248; relapsed/refractory FLT3-mutated AML for NCT02421939. · These are registry records and do not establish MFDS approval, routine access, reimbursement, current enrollment, or individual eligibility. Confidence/conflicts: High for registry-listed Korea trial status; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Momelotinib임상시험 · NCT06847867임상시험Trial only (NCT06847867)Korea · Very low/low/intermediate IPSS-R risk with blasts under 5% and anemia relapsed/refractory, intolerant, or ineligible after ESA or luspatercept context in registry; no mutation biomarker stated; Low-risk MDS-related anemia after one prior line with ESA or luspatercept, including relapsed/refractory, intolerant, or ineligible contexts described in eligibility. · Registry listing does not establish MFDS approval, reimbursement, routine access, or individual eligibility. This is a trial-only anemia-focused cell, not a general MDS treatment recommendation. Confidence/conflicts: High for registry facts; no approval claim made. ClinicalTrials.gov — clinical-trial registry
  • Ponatinib; dasatinib; imatinib; bosutinib; radotinib임상시험 · NCT02467270임상시험Trial only (NCT02467270)Korea · Philadelphia chromosome/BCR-ABL1; resistant chronic-phase CML for ponatinib study; Resistant chronic-phase CML; chronic-phase CML after inadequate imatinib response; newly diagnosed Ph-positive chronic-phase CML; extension after prior bosutinib studies. · These are completed trial records and do not establish MFDS approval, current access, reimbursement, or individual eligibility. Confidence/conflicts: High for historical trial-site status; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • asciminib (Scemblix)임상시험 · NCT05943522임상시험Trial only (NCT05943522)Korea · Philadelphia chromosome-positive CML; exact line and mutation context not specified by the post-approval surveillance listing; Post-approval surveillance of asciminib in Korea for CML. · This is a post-approval surveillance/trial listing, not a label or payer decision. Current MFDS indication boundaries, T315I status, prior-TKI requirements, and reimbursement must be verified separately. Confidence/conflicts: Medium for Korea post-approval surveillance signal; low for label/reimbursement detail. No conflict identified. Novartis Clinical Trials — Sponsor clinical-trial/post-approval surveillance listing
  • Autologous/donor-derived CD5 CAR T cells; allogeneic CD19-targeted CAR-gamma-delta T cells (QH10304-BAL-01) with fludarabine/cyclophosphamide conditioning임상시험 · NCT06316856임상시험Trial only (NCT06316856)China · CD5 for T-cell malignancy CAR-T study; CD19 for allogeneic CD19-targeted CAR-gamma-delta T-cell study; Relapsed/refractory T-cell ALL or T-cell malignancies; relapsed/refractory adult B-cell ALL. · Trial-only China records do not establish NMPA approval, routine availability, reimbursement, or individual eligibility. Some sites may be recruiting while others are not yet recruiting. Confidence/conflicts: High for registry-listed China trial status; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • BGB-16673; ibrutinib; chlorambucil; anti-CD19 CAR-T cells; BTK inhibitor plus fludarabine-based chemotherapy plus CAR-T-CD19 cells; CC312; selenious yeast supportive/investigational study임상시험 · NCT05006716임상시험Trial only (registry)China · CD19-positive context for CC312 and anti-CD19 CAR-T records; not mutation-restricted in the BGB-16673 or ibrutinib records; B-cell malignancies including CLL/SLL; relapsed/refractory CD19-positive B-cell hematologic malignancies; treatment-naive older CLL/SLL in historical ibrutinib studies; refractory/relapsed B-cell malignancy CAR-T contexts. · Registry records do not establish NMPA approval, routine access, reimbursement, or individual eligibility. Unknown-status records require direct site confirmation before patient-facing use; supportive/investigational nutrition-adjacent studies should not be framed as standard anti-cancer treatment. Confidence/conflicts: Medium-high; multiple unknown-status China CAR-T records need direct confirmation, and no NMPA approval is inferred. ClinicalTrials.gov — clinical-trial registry
  • Dasatinib; imatinib; TGRX-678; nilotinib; bosutinib; CD123-CD33 cCAR T cells in broader hematologic malignancy study including CML임상시험 · NCT06453902임상시험Trial only (NCT06453902)China · BCR-ABL1/Philadelphia chromosome context; Chronic-phase CML; accelerated-phase CML; newly diagnosed chronic-phase CML; relapsed/refractory high-risk hematologic malignancy context including CML. · Registry records do not establish NMPA approval, reimbursement, routine access, or individual eligibility. Unknown-status records need direct site confirmation. Confidence/conflicts: Medium-high; unknown-status China studies require direct confirmation. ClinicalTrials.gov — clinical-trial registry
  • Ivosidenib/AG-120 with azacitidine; venetoclax with homoharringtonine and cytarabine; gilteritinib versus salvage chemotherapy; lisaftoclax/APG-2575 with azacitidine임상시험 · NCT03173248임상시험Trial only (NCT03173248)China · IDH1 mutation for ivosidenib-azacitidine; FLT3 mutation for gilteritinib salvage study; not mutation-restricted in venetoclax-homoharringtonine-cytarabine or lisaftoclax-azacitidine registry fields; Untreated IDH1-mutated AML; AML induction; relapsed/refractory FLT3-mutated AML; AML treatment study with lisaftoclax plus azacitidine. · Registry records do not establish NMPA approval, reimbursement, routine availability, current enrollment for each site, or individual eligibility. Confidence/conflicts: High for registry-listed China trial status; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Lisaftoclax (APG-2575) plus azacitidine versus placebo plus azacitidine임상시험 · NCT06641414임상시험Trial only (NCT06641414)China · Higher-risk MDS category; no mutation biomarker stated; Newly diagnosed higher-risk MDS. · Registry listing does not establish NMPA approval, reimbursement, routine access, or individual eligibility. Lisaftoclax is recorded as an investigational trial intervention in this cell. Confidence/conflicts: High for registry facts; no conflict identified. ClinicalTrials.gov — clinical-trial registry
  • TQ05105 tablets plus TQB3617 capsules; ruxolitinib임상시험 · NCT06122831임상시험Trial only (NCT06122831)China · No mutation biomarker required by the fetched China records; DIPSS intermediate/high risk, prior JAK inhibitor context, splenomegaly, or prior ruxolitinib use appear in eligibility depending on study; NCT06122831 includes intermediate/high-risk MF, with cohorts for poor efficacy of JAK inhibitors and JAK-inhibitor-naive treatment. NCT05447260 includes primary or secondary MF patients who have received ruxolitinib for at least 3 months. · Registry entries do not establish NMPA approval, China reimbursement, local routine access, or individual eligibility. NCT05447260 has overall status unknown despite a site listed as recruiting; NCT06122831 China sites fetched this cycle were not-yet-recruiting. Confidence/conflicts: Medium-high for registry facts; status caveat noted where overall status and site status differ. ClinicalTrials.gov — clinical-trial registry
  • Blinatumomab; personalized targeted preparative regimen before T-depleted allogeneic HSCT; carfilzomib plus induction chemotherapy임상시험 · NCT04723342임상시험Trial only (NCT04723342)Russia · B-precursor context for blinatumomab comparator study; not otherwise specified in fetched fields; Childhood ALL protocol; refractory pediatric ALL before allogeneic HSCT; relapsed/refractory B-precursor ALL; relapsed/refractory pediatric ALL. · Registry records do not establish Roszdravnadzor approval, reimbursement, routine access, or individual eligibility. Several Russia records have overall-status unknown or terminated/completed status and need site confirmation before clinical discussion. Confidence/conflicts: Medium-high; Russia cells include unknown-status and closed studies, so current availability needs direct confirmation. ClinicalTrials.gov — clinical-trial registry
  • Ibrutinib; chlorambucil; venetoclax; rituximab; bendamustine; acalabrutinib; obinutuzumab; fludarabine; cyclophosphamide; navitoclax/ABT-263임상시험 · NCT01722487임상시험Trial only (registry)Russia · Not mutation-restricted in the cited registry records; Treatment-naive CLL/SLL in older adults or broad first-line settings; relapsed/refractory CLL for venetoclax-rituximab study; untreated and relapsed/refractory CLL safety context for acalabrutinib. · Registry records do not establish Roszdravnadzor approval, reimbursement, routine access, or individual eligibility. The cited Russia-site records are completed or historical rather than currently recruiting disease-directed CLL trials. Confidence/conflicts: High for completed registry status; no Russian regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Imetelstat sodium versus placebo임상시험 · NCT02598661임상시험Trial only (NCT02598661)Russia · IPSS low or intermediate-1 risk; no mutation biomarker stated; Transfusion-dependent low or intermediate-1 risk MDS after ESA relapsed/refractory setting. · Registry listing does not establish Russian regulator approval, reimbursement, routine access, active enrollment, or individual eligibility. Overall status is active-not-recruiting, and Russia site statuses were not shown as recruiting in fetched location lines. Confidence/conflicts: High for registry facts; no Russia approval claim made. ClinicalTrials.gov — clinical-trial registry
  • Ivosidenib/AG-120 with azacitidine; APG-2575/lisaftoclax with azacitidine; personalized targeted preparative regimen before T-depleted allogeneic HSCT임상시험 · NCT03173248임상시험Trial only (NCT03173248)Russia · IDH1 mutation for ivosidenib-azacitidine; not specified for lisaftoclax-azacitidine; refractory acute leukemia for preparative HSCT regimen; Untreated IDH1-mutated AML; AML treatment with lisaftoclax plus azacitidine; refractory pediatric acute leukemia/AML before allogeneic HSCT. · Registry records do not establish Roszdravnadzor approval, routine availability, reimbursement, or individual eligibility. Pediatric transplant preparative regimen is investigational/trial context and not a stand-alone AML therapy. Confidence/conflicts: Medium-high; NCT04000698 overall status unknown versus site query recruiting requires direct confirmation. ClinicalTrials.gov — clinical-trial registry
  • KRT-232; TL-895; pacritinib versus physician's choice medications임상시험 · NCT04878003임상시험Trial only (NCT04878003)Russia · No mutation biomarker required by fetched Russia records; DIPSS risk, prior JAK inhibitor exposure, severe thrombocytopenia, splenomegaly, and symptom-score criteria appear depending on study; JAK-inhibitor-treatment-naive MF with intermediate/high-risk disease for NCT04878003; MF with platelet count under 50,000/microliter and intermediate/high-risk disease for NCT03165734. · Registry entries do not establish Russian regulator approval, reimbursement, local routine availability, active enrollment beyond stated site statuses, or individual eligibility. NCT04878003 overall status is unknown despite Russia sites listed as recruiting. Confidence/conflicts: Medium-high for registry facts; unknown-status caveat recorded. ClinicalTrials.gov — clinical-trial registry
  • Ponatinib; nilotinib; bosutinib; dasatinib; imatinib; pegylated or recombinant interferon alfa in prior-study continuation context; allogeneic HCT supportive supplementation context임상시험 · NCT02467270임상시험Trial only (registry)Russia · Philadelphia chromosome/BCR-ABL1; resistant chronic-phase CML for ponatinib study; Resistant chronic-phase CML; newly diagnosed or chronic-phase CML; CML after prior bosutinib studies; allogeneic HCT population including CML. · Registry records do not establish Roszdravnadzor approval, routine access, reimbursement, or individual eligibility. Many cited studies are completed; recruiting HCT supplementation is supportive/trial context rather than CML-directed disease therapy. Confidence/conflicts: High for completed registry status; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Risk-stratified multiagent protocol including cyclophosphamide, cytarabine, dexamethasone, etoposide, ifosfamide, methotrexate, vincristine, doxorubicin hydrochloride, carboplatin, nitrosourea (CCNU/BCNU), melphalan, and idarubicin in protocol arms as listed임상시험 · NCT05518383임상시험Trial only (NCT05518383)Russia · Mature B-cell NHL / Burkitt category; no mutation biomarker stated; Children and adolescents aged 0 to 18 years with mature B-cell NHL including Burkitt lymphoma, diffuse large B-cell lymphoma, primary mediastinal lymphoma, primary CNS lymphoma, or B-cell (Burkitt) acute leukemia. · Registry listing does not establish Russian regulator approval, reimbursement, routine access, open enrollment for every subgroup, or individual eligibility. The intervention list is a protocol component list, not a recommendation or dosing guide. Confidence/conflicts: High for Russia trial registry fact; no conflict identified. ClinicalTrials.gov — clinical-trial registry
  • CD19-IL7Ra CAR-T cells (CMD63); carfilzomib plus induction chemotherapy; multiagent chemotherapy for Down syndrome ALL protocol임상시험 · NCT07078929임상시험Trial only (NCT07078929)Thailand · CD19 target for CMD63 CAR-T study; Down syndrome subgroup for ASIA DS-ALL study; Relapsed/refractory childhood B-ALL; relapsed/refractory pediatric ALL; Down syndrome-associated childhood ALL protocol context. · Registry records do not establish Thai FDA approval, reimbursement, routine access, or individual eligibility. In NCT07078929, Thailand site statuses include recruiting and not-yet-recruiting. Confidence/conflicts: High for registry status; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Dasatinib; imatinib; nilotinib; radotinib; bosutinib임상시험 · NCT01593254임상시험Trial only (NCT01593254)Thailand · Philadelphia chromosome/BCR-ABL1; Newly diagnosed or chronic-phase CML; inadequate response to imatinib; bosutinib extension after prior studies. · These are historical completed/expanded-access trial records and do not establish Thai FDA approval, reimbursement, current enrollment, or routine access. Confidence/conflicts: High for historical registry status; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Elritercept versus placebo임상시험 · NCT06499285임상시험Trial only (NCT06499285)Thailand · MDS with or without ring sideroblasts; IPSS-R very low, low, or intermediate risk; no mutation biomarker stated; Adults with very low, low, or intermediate-risk MDS, with or without ring sideroblasts, and transfusion dependence as defined in the registry. · Registry listing does not establish Thai FDA approval, reimbursement, routine access, active Thailand enrollment, or individual eligibility. The Thailand site statuses returned as not-yet-recruiting despite the overall recruiting status. Confidence/conflicts: High for registry facts; site-level and overall status differ, so access confidence is lower. ClinicalTrials.gov — clinical-trial registry
  • Gilteritinib versus salvage chemotherapy; autologous multi-lineage potential cells (AMPC)임상시험 · NCT03182244임상시험Trial only (NCT03182244)Thailand · FLT3 mutation for gilteritinib salvage study; not specified for AMPC recurrent AML study; Relapsed/refractory FLT3-mutated AML; recurrent AML. · Registry records do not establish Thai FDA approval, reimbursement, routine access, or current enrollment. NCT03825146 has overall status unknown and needs direct site confirmation. Confidence/conflicts: Medium-high; NCT03825146 status conflict requires site confirmation. ClinicalTrials.gov — clinical-trial registry
  • Nemtabrutinib; ibrutinib; acalabrutinib; acalabrutinib versus chlorambucil plus rituximab; obinutuzumab; rituximab; chlorambucil; bendamustine; cyclophosphamide; fludarabine임상시험 · NCT06136559임상시험Trial only (registry)Thailand · Not mutation-restricted in the cited registry records; First-line CLL/SLL for NCT06136559; previously untreated CLL for NCT04075292 and obinutuzumab/chlorambucil studies; relapsed CLL for historical ofatumumab-fludarabine-cyclophosphamide context in search results not used as a primary source in this finding. · Registry records do not establish Thai FDA approval, reimbursement, routine access, or individual eligibility. Completed studies are historical; active-not-recruiting and recruiting statuses should be confirmed with participating Thai centers. Confidence/conflicts: High for registry-listed Thailand sites; no Thai regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
  • Pelabresib plus ruxolitinib; luspatercept; KRT-232 versus best available therapy임상시험 · NCT04603495임상시험Trial only (NCT04603495)Thailand · No mutation biomarker required by fetched Thailand records; symptomatic disease, splenomegaly, DIPSS risk, parent-trial participation, or relapsed/refractory to JAK inhibitor context appear in eligibility depending on study; JAK-inhibitor-naive MF with symptoms and splenomegaly for NCT04603495; parent-trial luspatercept continuation or crossover context for NCT04064060; relapsed/refractory to JAK inhibitor treatment for NCT03662126. · Registry records do not establish Thai FDA approval, reimbursement, local routine availability, active enrollment beyond stated site statuses, or individual eligibility. NCT03662126 overall status is unknown despite Thailand sites listed as recruiting. Confidence/conflicts: Medium-high for registry facts; unknown-status conflict/caveat recorded. ClinicalTrials.gov — clinical-trial registry
  • Canadian Cancer Trials Group hematology trials including ALC10, ALC8, AL6, and ALC7/myeloMATCH biomarker matching임상시험임상시험Reported in a clinical trialCanada · FLT3 mutation; high-risk AML; myeloMATCH biomarker testing context; AML clinical-trial screening and biomarker-matched trial pathways. · The fetched page provides high-level trial descriptions, not full eligibility, recruitment status by site, or protocol details. Trial access depends on open status, location, biomarkers, age, and protocol criteria. Confidence/conflicts: Medium-high for high-level Canadian AML trial availability framework; protocol-level details remain a gap. No conflict identified. Canadian Cancer Trials Group — Canadian hematologic clinical trials listing

임상시험이나 초기 보고에 실렸다는 것은 해당 선택지가 연구되고 있다는 의미일 뿐, 효과가 있거나 특정 환자에게 안전하거나 현재 등록 가능하다는 뜻은 아닙니다. 어떤 선택지가 적합한지는 담당 종양내과 팀과 임상시험 팀이 함께 상의할 문제입니다. 최종 확인 2026.06.

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acute myeloid leukemia molecular testing clinical trialacute lymphoblastic leukemia clinical trialchronic lymphocytic leukemia clinical trialchronic myeloid leukemia BCR-ABL clinical trialleukemia stem cell transplant clinical trial