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림프종 및 골수종: 국가별 치료 선택지
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국가별 선택지
국가별 치료 선택지
공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.
Hodgkin lymphoma
United States
- nivolumab (Opdivo) + AVD[1]FDA-approvedpreviously untreated stage III or IV classic Hodgkin lymphoma, adults · Approved in combination with doxorubicin, vinblastine and dacarbazine (AVD); regulatory fact, not an eligibility determination.
European Union
- brentuximab vedotin (Adcetris)[2]EMA-authorised (central marketing authorisation)CD30-positive Hodgkin lymphoma: previously untreated advanced disease (with chemotherapy), post-ASCT consolidation at increased risk, and relapsed/refractory cHL · Central EU authorisation only; member-state reimbursement not verified.
- pembrolizumab (Keytruda)[3]EMA-authorised (central marketing authorisation)relapsed or refractory classic Hodgkin lymphoma, adults and paediatric patients · Multi-indication EPAR; consult the product information for the Hodgkin lymphoma indication. Member-state reimbursement not verified.
United Kingdom
- brentuximab vedotin (Adcetris) + AVD[4]NICE-recommended on the NHS (England)previously untreated stage III–IV CD30-positive Hodgkin lymphoma, adults · Recommended only under the commercial arrangement; NHS England context, not a universal UK availability statement.
Diffuse large B-cell lymphoma
United States
- epcoritamab-bysp (Epkinly)[5]FDA-approved (accelerated approval)relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy · Accelerated approval; a bispecific (CD3 x CD20) antibody with cytokine release syndrome warnings.
- glofitamab-gxbm (Columvi)[6]FDA-approved (accelerated approval)selected relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy · Accelerated approval; a fixed-duration bispecific (CD3 x CD20) antibody with cytokine release syndrome warnings.
- Pola-R-CHP (polatuzumab vedotin + rituximab + cyclophosphamide + doxorubicin + prednisone)[9]NCI PDQ: listed among standard treatment optionspreviously untreated DLBCL, listed among standard first-line options · PDQ is an information summary, not patient-specific eligibility.
European Union
- polatuzumab vedotin (Polivy)[7]EMA-authorised (central marketing authorisation)previously untreated DLBCL (with R-CHP) and relapsed/refractory DLBCL (with bendamustine and rituximab) · Central EU authorisation only; member-state reimbursement not verified.
- glofitamab (Columvi)[8]EMA-authorised (central marketing authorisation)relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy, adults · Central EU authorisation only; member-state reimbursement not verified.
Follicular lymphoma
United States
- mosunetuzumab-axgb (Lunsumio)[10]FDA-approved (accelerated approval)relapsed or refractory follicular lymphoma after two or more lines of systemic therapy · Accelerated approval; a bispecific (CD3 x CD20) antibody.
- epcoritamab-bysp (Epkinly)[11]FDA-approvedrelapsed or refractory follicular lymphoma indications · A bispecific (CD3 x CD20) antibody; prescribing information includes cytokine release syndrome warnings.
- rituximab (+ chemotherapy)[12]NCI PDQ: listed among standard treatment optionsindolent (follicular) B-cell lymphoma; rituximab-based chemoimmunotherapy among standard options · PDQ is an information summary, not patient-specific eligibility.
Mantle cell lymphoma
United States
- acalabrutinib (Calquence) + bendamustine + rituximab[13]FDA-approvedpreviously untreated mantle cell lymphoma
- pirtobrutinib (Jaypirca)[14]FDA-approved (accelerated approval)relapsed or refractory mantle cell lymphoma after two or more lines, including a BTK inhibitor · Accelerated approval; a non-covalent (reversible) BTK inhibitor.
European Union
- brexucabtagene autoleucel (Tecartus)[15]EMA-authorised (central marketing authorisation)relapsed or refractory mantle cell lymphoma after a BTK inhibitor, adults · Central EU authorisation only; CAR T-cell therapy delivered at qualified centres. Member-state reimbursement not verified.
- ibrutinib (Imbruvica)[16]EMA-authorised (central marketing authorisation)relapsed or refractory mantle cell lymphoma, adults · Central EU authorisation only; member-state reimbursement not verified.
Multiple myeloma
United States
- teclistamab (Tecvayli) + daratumumab/hyaluronidase (Darzalex)[17]FDA-approvedrelapsed or refractory multiple myeloma · Teclistamab is a BCMA x CD3 bispecific with cytokine release syndrome warnings.
European Union
- daratumumab (Darzalex)[18]EMA-authorised (central marketing authorisation)newly diagnosed and relapsed/refractory multiple myeloma, product-specific contexts · Central EU authorisation only; member-state reimbursement not verified.
- ciltacabtagene autoleucel (Carvykti)[19]EMA-authorised (central marketing authorisation)relapsed and refractory multiple myeloma, adults · Central EU authorisation only; BCMA-directed CAR T-cell therapy delivered at qualified centres. Member-state reimbursement not verified.
United Kingdom
- teclistamab (Tecvayli)[20]NICE-recommended on the NHS (England)relapsed and refractory multiple myeloma after three or more prior therapies · Recommended under the commercial arrangement; NHS England context, not a universal UK availability statement.
Lymphoma & myeloma
United States
- Acalabrutinib (Calquence) with bendamustine and rituximab; acalabrutinib monotherapy; pirtobrutinib (Jaypirca); sonrotoclax (Beqalzi); brexucabtagene autoleucel (Tecartus); zanubrutinib (Brukinsa) formulation entry for MCL after at least one prior therapy[13]FDA accelerated approvalCD19 relevant to brexucabtagene autoleucel; BTK inhibitor prior exposure relevant to pirtobrutinib and sonrotoclax post-BTK settings; no mutation biomarker stated; Previously untreated MCL in adults ineligible for autologous HSCT for acalabrutinib plus bendamustine/rituximab; previously treated MCL for acalabrutinib monotherapy; relapsed/refractory MCL after two or more systemic therapy lines including a BTK inhibitor for pirtobrutinib and sonrotoclax; relapsed/refractory MCL for Tecartus; MCL after at least one prior therapy for zanubrutinib formulation accelerated-approval listing. · FDA sources verify U.S. regulatory status only and do not establish payer coverage, sequencing, center availability for CAR T-cell therapy, or individual eligibility. Pirtobrutinib, sonrotoclax, and the zanubrutinib formulation entry are accelerated-approval/ongoing contexts as stated by FDA, with continued approval contingent on confirmatory evidence where applicable. Confidence/conflicts: High for FDA approval statements; no conflict identified, but accelerated approvals require confirmatory-benefit tracking.
- Combination chemotherapy including ABVD/AVD-family regimens; radiation therapy; nivolumab (Opdivo) with doxorubicin, vinblastine, and dacarbazine (AVD); pembrolizumab (Keytruda); brentuximab vedotin (Adcetris); brentuximab vedotin plus nivolumab; chemotherapy with stem cell transplant; rituximab for NLPHL contexts; watchful waiting/active surveillance for selected NLPHL contexts[1]FDA-approvedCD30-positive context for brentuximab vedotin; no mutation biomarker required for broad NCI treatment categories; PD-1 pathway therapy context for nivolumab/pembrolizumab; Early favorable/unfavorable classic HL; advanced classic HL; recurrent classic HL; NLPHL; previously untreated stage III or IV cHL age 12+ for nivolumab-AVD; adult relapsed/refractory cHL after autologous HSCT and brentuximab vedotin or after three or more systemic therapy lines including autologous HSCT for nivolumab. · NCI PDQ is an evidence summary, not an individualized treatment plan or payer rule. FDA approval wording does not establish payer coverage, center access, transplant eligibility, or suitability for a specific patient. Stem cell transplant is cataloged as a treatment modality to discuss with a specialist team, not as a recommendation. Confidence/conflicts: High for NCI treatment categories and FDA nivolumab approval wording; no conflict recorded.
- Monoclonal antibodies including daratumumab, elotuzumab, isatuximab; proteasome inhibitors; immunomodulatory agents; CAR T-cell therapy; bispecific antibody therapy including teclistamab (Tecvayli); teclistamab plus daratumumab hyaluronidase-fihj; chemotherapy/cytotoxic agents; selinexor; venetoclax; BRAF/MEK inhibitors; corticosteroids; autologous or allogeneic SCT in selected relapsed/refractory contexts[17]FDA-approvedBCMA relevant to CAR T and bispecific antibody options; CD38 relevant to daratumumab; t(11;14) and BRAF/MEK contexts are discussed in NCI relapsed/refractory option categories; no single required biomarker across all options; Relapsed or refractory multiple myeloma; FDA-specific teclistamab-daratumumab after at least one prior line including PI and IMiD; FDA-specific teclistamab monotherapy after at least four prior lines including PI, IMiD, and anti-CD38 monoclonal antibody. · NCI PDQ is an evidence summary and does not establish payer coverage, center capability, product-specific eligibility, or superiority. FDA approval notice supports only the specified teclistamab settings and does not define all local access requirements. Confidence/conflicts: High for NCI option categories and FDA teclistamab approval; no conflict identified.
- Polatuzumab vedotin with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP); R-CHOP; CAR T-cell therapies including axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel contexts in NCI summary; tafasitamab plus lenalidomide; epcoritamab (Epkinly); glofitamab (Columvi); polatuzumab vedotin plus bendamustine and rituximab; loncastuximab tesirine; rituximab plus lenalidomide; palliative radiation therapy; stem cell transplant consolidation[5]FDA accelerated approvalCD20-directed context for rituximab and CD20xCD3 bispecifics; CD19-directed CAR T-cell context; high-risk MYC/BCL2 features noted by NCI as prognostic rather than eligibility for every option; Advanced-stage DLBCL first-line context for Pola-R-CHP/R-CHOP; relapsed/refractory or primary refractory settings including post-autologous SCT contexts for CAR T-cell/SCT/targeted options; after two or more systemic therapy lines for FDA epcoritamab and glofitamab approvals. · NCI PDQ is an evidence summary and does not establish payer coverage, product label limits, center access, or individual eligibility. FDA accelerated approvals are specific to labeled relapsed/refractory settings and require current label/REMS and confirmatory-status review before patient-facing reuse. Confidence/conflicts: High for NCI category coverage and FDA approval notices; current label details for all named products remain active gaps.
- Radiation therapy; rituximab (Rituxan and biosimilars); obinutuzumab (Gazyva); chemotherapy and chemoimmunotherapy combinations; lenalidomide plus rituximab; zanubrutinib plus obinutuzumab; mosunetuzumab-axgb (Lunsumio); epcoritamab-bysp (Epkinly) with lenalidomide and rituximab or as monotherapy; CD19-directed CAR T-cell therapy; stem cell transplant in selected contexts; palliative radiation; tazemetostat (Tazverik) as historical/withdrawn context only[21]FDA accelerated approvalEZH2 mutation historically relevant to tazemetostat; CD20 and CD3 relevant to bispecific antibody mechanisms; CD19 relevant to CAR T-cell therapy; no mutation biomarker stated for many listed options; Early-stage indolent NHL radiation; indolent recurrent B-cell NHL; relapsed/refractory follicular lymphoma after two or more lines for mosunetuzumab and epcoritamab monotherapy; relapsed/refractory follicular lymphoma for epcoritamab plus lenalidomide and rituximab as stated by FDA; historical tazemetostat relapsed/refractory settings no longer current based on FDA withdrawal alert. · NCI PDQ is a treatment evidence summary and does not itself establish product-specific FDA label status, payer coverage, local access, or individual eligibility. FDA notices verify U.S. regulatory status only. Tazemetostat has conflicting historical/current status across FDA pages: the 2020 accelerated approval notice is superseded for availability purposes by the fetched FDA withdrawal alert. Confidence/conflicts: High for FDA approvals and NCI option categories; explicit conflict noted between historical tazemetostat accelerated approval and later FDA withdrawal alert. The FDA voluntary withdrawal of Tazverik (tazemetostat) — announced by Ipsen 9 March 2026, FDA alert 13 May 2026, for hematologic second-primary-malignancy risk per SYMPHONY-1 — is COMPLETE for BOTH follicular lymphoma and epithelioid sarcoma; there is no remaining live US availability and the 2020 accelerated approval is fully superseded. The bundle's dominant options (mosunetuzumab/Lunsumio, epcoritamab/Epkinly, rituximab, obinutuzumab, CD19 CAR-T) remain genuinely FDA-approved, so the 'restricted' top-line is defensible.
- Zanubrutinib (Brukinsa); ibrutinib (Imbruvica) alone or with rituximab; rituximab; bendamustine; alkylating agents; nucleoside analogues; plasmapheresis for hyperviscosity symptoms[22]FDA-approvedMYD88 variant commonly present; FDA zanubrutinib approval source discusses ASPEN MYD88-mutated and MYD88-wildtype/unknown cohorts; no individualized biomarker recommendation made here; Adults with WM for FDA zanubrutinib and ibrutinib label claims; asymptomatic monitoring, hyperviscosity supportive management, and symptomatic WM treatment contexts from NCI PDQ. · FDA labels/approval notices do not establish insurance coverage or treatment suitability. NCI PDQ is an evidence summary, not a formal clinical-practice guideline or personalized recommendation. Confidence/conflicts: High for FDA approval/label and NCI evidence-summary content; ibrutinib label PDF includes an internal note that newer labeling may exist, so current-label refresh remains a gap.
- anemia supportive care including transfusion, erythropoiesis-stimulating agents (ESAs), and correction of iron, vitamin B12, or folate deficiency when present[23]Standard option (per NSSG / British Society for Haematology-linked supportive care guideline PDF)not biomarker-specific; Symptomatic or treatment-associated anemia in multiple myeloma; supportive management alongside disease-directed therapy. · Anemia management depends on cause, symptoms, hemoglobin trend, marrow disease, renal function, iron/B12/folate status, thrombosis risk, and treatment goals. This entry does not define transfusion thresholds or ESA eligibility for an individual patient. Confidence/conflicts: Medium-high for supportive categories; exact thresholds and ESA restrictions need current national/local guideline verification. No conflict identified.
- bone-modifying agents including bisphosphonates and denosumab[24]Standard option (per American Society of Clinical Oncology / Journal of Clinical Oncology)not biomarker-specific; Supportive management of multiple myeloma-related bone disease and skeletal-related-event risk. · This is a professional guideline source, not individualized advice. Choice of agent depends on renal function, toxicity profile, dental status, cost/access, and clinician judgment. Do not surface dosing details from the guideline block without oncology review. Confidence/conflicts: High for ASCO guideline context; individual coverage and product-label details vary by payer. No conflict identified.
- nivolumab (Opdivo) with doxorubicin, vinblastine, and dacarbazine (AVD); nivolumab monotherapy in relapsed/refractory contexts[1]FDA-approvedPD-1 checkpoint inhibitor context; no biomarker restriction stated in FDA notice; Previously untreated stage III/IV cHL age 12+ with AVD; adult relapsed/refractory cHL after auto-HSCT plus brentuximab or after at least three systemic therapy lines including auto-HSCT. · FDA approval does not establish individual eligibility, pediatric center availability, insurance coverage, or sequencing against brentuximab-containing regimens. This entry does not provide dosing. Confidence/conflicts: High for U.S. FDA approval scope; no conflict identified.
European Union
- Brentuximab vedotin (Adcetris); nivolumab (Opdivo); pembrolizumab (Keytruda); doxorubicin, vinblastine, and dacarbazine (AVD); etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone combination context; brentuximab vedotin plus nivolumab[2]EMA authorisedCD30-positive requirement for brentuximab vedotin (Adcetris); PD-1 therapy context for nivolumab and pembrolizumab; no molecular mutation restriction stated in the captured EMA cHL indication snippets; Previously untreated advanced CD30-positive HL/cHL; post-ASCT consolidation or relapse/refractory settings; relapsed/refractory cHL after ASCT or after prior therapies where ASCT is not an option; pediatric/young adult relapsed/refractory cHL after one prior line for Opdivo plus brentuximab vedotin. · EMA central authorisation does not establish reimbursement or access in Germany, France, or other EU member states. Product information should be checked for exact age, combination, line-of-therapy, and safety details before patient-facing reuse. Confidence/conflicts: High for EMA EPAR indication summaries; member-state reimbursement remains an active gap.
- Daratumumab (Darzalex) in multiple combinations or monotherapy settings; teclistamab (Tecvayli) monotherapy; ciltacabtagene autoleucel (Carvykti)[18]EMA authorisedCD38 relevant to daratumumab (Darzalex); BCMA relevant to teclistamab (Tecvayli) and ciltacabtagene autoleucel (Carvykti); no mutation biomarker stated; Newly diagnosed multiple myeloma in Darzalex product-specific transplant-eligible and transplant-ineligible combinations; relapsed/refractory multiple myeloma in Darzalex, Tecvayli, and Carvykti product-specific settings. · EMA central authorisation does not establish Germany, France, or other member-state reimbursement, hospital access, manufacturing slot availability for CAR T, or individual eligibility. Tecvayli has conditional authorisation and additional monitoring in the fetched EMA page; Carvykti is an ATMP and additional-monitoring product. Confidence/conflicts: High for EMA indications; no conflict identified.
- Epcoritamab (Tepkinly); glofitamab (Columvi); polatuzumab vedotin (Polivy); rituximab; cyclophosphamide; doxorubicin; prednisone; bendamustine; gemcitabine; oxaliplatin[25]EMA authorisedCD20xCD3 bispecific context for epcoritamab and glofitamab; CD79b-targeted antibody-drug conjugate context for polatuzumab vedotin; no mutation biomarker stated in captured EMA indication summaries; Previously untreated DLBCL for Polivy plus R-CHP components; relapsed/refractory after at least two prior treatments for Tepkinly and Columvi; relapsed/refractory transplant-ineligible contexts for Columvi combination and Polivy-bendamustine-rituximab. · EMA central authorisation does not establish reimbursement or access in Germany, France, or other member states. Exact label, combination, CRS monitoring, and center requirements should be checked in product information before patient-facing reuse. Confidence/conflicts: High for EMA EPAR indication summaries; member-state reimbursement remains an active gap.
- Ibrutinib (Imbruvica); pirtobrutinib (Jaypirca); brexucabtagene autoleucel (Tecartus)[16]EMA authorisedCD19 relevant to Tecartus; prior BTK inhibitor exposure relevant to Jaypirca; no mutation biomarker stated; Previously untreated MCL in transplant-eligible adults for Imbruvica-containing alternating regimen; relapsed/refractory or previously treated MCL for Imbruvica monotherapy; relapsed/refractory MCL after prior BTK inhibitor for Jaypirca; relapsed/refractory MCL after two or more systemic therapy lines including a BTK inhibitor for Tecartus. · EMA central authorisation does not establish access, reimbursement, or availability in a specific EU member state such as Germany or France. Jaypirca and Tecartus have conditional/additional-monitoring context; Tecartus requires specialist hospital capability and patient-specific cell manufacture. Brukinsa was checked on EMA but the fetched page did not support an MCL indication, so no EU Brukinsa MCL claim is recorded. Confidence/conflicts: High for Imbruvica, Jaypirca, and Tecartus EMA MCL authorisation language. Brukinsa EU MCL status remains unverified from the fetched EMA page and is not recorded as an EU MCL option.
- Mosunetuzumab (Lunsumio); epcoritamab (Tepkinly); rituximab (MabThera); obinutuzumab (Gazyvaro); chemotherapy and bendamustine in the EMA-described obinutuzumab contexts; lenalidomide comparator context for additional Lunsumio evidence[26]EMA authorisedCD20 and CD3 relevant to mosunetuzumab/epcoritamab mechanisms; CD20 relevant to rituximab and obinutuzumab; no mutation biomarker stated; Relapsed/refractory follicular lymphoma after at least two previous treatments for Lunsumio and Tepkinly; previously untreated advanced follicular lymphoma and rituximab-refractory/progressing follicular lymphoma contexts for Gazyvaro as described by EMA; follicular lymphoma indication for MabThera. · EMA central authorisation does not establish access, reimbursement, or availability in a specific EU member state such as Germany or France. Lunsumio is conditionally authorised, and EMA states further comparative data are required. This finding does not infer sequencing or eligibility beyond the EMA pages. Confidence/conflicts: High for EU central authorisation statements; no conflict identified, but member-state reimbursement remains unresolved.
- Zanubrutinib (Brukinsa); ibrutinib (Imbruvica) alone or with rituximab[27]EMA authorisedNo mutation biomarker required by fetched EMA indication text; Prior-therapy WM or first-line chemo-immunotherapy-unsuitable WM for zanubrutinib; adult WM for ibrutinib alone or with rituximab per EMA overview. · EMA central authorization does not establish member-state reimbursement, local formulary access, or suitability. Germany/France reimbursement and HTA status remain separate cells. Confidence/conflicts: High for EMA central indication/overview facts; no conflict identified, but member-state access is unverified.
- brentuximab vedotin (Adcetris)[28]ApprovedCD30-positive Hodgkin lymphoma; Post-ASCT consolidation/maintenance in adult CD30+ HL at increased relapse/progression risk. · HAS page is French/English mixed and should be checked against the full opinion for legal nuance. This entry does not establish individual transplant eligibility or exact reimbursement administration route. Confidence/conflicts: High for HAS reimbursement opinion scope; no conflict identified.
- brentuximab vedotin (Adcetris) with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (ECADD)[29]ApprovedCD30-positive Hodgkin lymphoma implied by Adcetris mechanism; source frames Hodgkin lymphoma indication; Adult newly diagnosed stage IIb with risk factors, stage III, or stage IV Hodgkin lymphoma in the EU. · Company press release; EMA product information and member-state reimbursement are needed for exact implementation. This entry does not compare ECADD with AVD-based regimens or define individual eligibility. Confidence/conflicts: Medium-high for EU approval signal; EMA product-info and national reimbursement remain gaps. No conflict identified. A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
- brentuximab vedotin (Adcetris), nivolumab (Opdivo), pembrolizumab (Keytruda)[28]HAS reimbursement opinionCD30-positive context for brentuximab; PD-1 context for nivolumab/pembrolizumab; Third-line post-ASCT relapsed/refractory HL with Adcetris; fourth-line post-brentuximab PD-1 inhibitor salvage context. · This is pathway language within a HAS Adcetris opinion, not a dedicated HAS opinion for nivolumab or pembrolizumab. Direct French reimbursement details for PD-1 inhibitors in HL should be verified separately. Confidence/conflicts: Medium-high for HAS care-pathway context; direct PD-1 reimbursement remains a gap. No conflict identified.
- brexucabtagene autoleucel (Tecartus)[30]ApprovedCD19-directed CAR-T context; BTK inhibitor prior-treatment context; Third-line-or-later treatment for adult R/R MCL after at least two systemic therapies including a BTK inhibitor. · HAS states that Tecartus remains a third-line-or-later treatment but says its place in the strategy cannot be robustly established from updated ZUMA-2 and registry data. HAS highlights significant short-term toxicity, CRS/neurologic adverse events, prolonged hospitalization, distance from qualified centers, manufacturing/logistics delays, and the need for patient condition/life expectancy compatible with the process. Confidence/conflicts: High for HAS maintained reimbursement scope and caveats. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
- brexucabtagene autoleucel / autologous anti-CD19-transduced CD3-positive cells (Tecartus)[31]EMA authorisedCD19-directed CAR-T context; BTK inhibitor prior-treatment context; Adult R/R MCL after two or more systemic therapies including a BTK inhibitor. · German-language G-BA documents require human translation review for patient-facing reuse. The accompanying-data-collection requirement specifies comparative registry/data-platform expectations and does not itself establish individual eligibility or center capacity. CAR-T access depends on certified centers, manufacturing, inpatient monitoring, and payer/process requirements. Confidence/conflicts: High for G-BA indication and data-collection status. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team. A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
- ciltacabtagene autoleucel (Carvykti)[32]ApprovedBCMA-targeted CAR T-cell therapy context; lenalidomide-refractory setting; Adult relapsed/refractory myeloma after at least one prior therapy; subgrouped by one to three versus at least four prior therapies in the German benefit assessment. · This is a German AMNOG benefit-assessment resolution, not a statement that every patient can receive CAR-T. G-BA notes uncertainty about transferability to German care and eligibility for CAR-T, and the resolution is a courtesy translation with German legally binding. Confidence/conflicts: High for German HTA wording; no conflict identified, but subgroup-specific benefit differs by prior-line count.
- ciltacabtagene autoleucel (Carvykti)[33]ApprovedBCMA-targeted CAR T-cell therapy context; Fourth-line or subsequent relapsed/refractory myeloma. · HAS notes the lack of methodologically robust comparative data, the time required for CAR-T availability, significant short-term toxicity, and the need for patient health and life expectancy to be compatible with the process. HAS says administration is limited to qualified CAR-T centers. Confidence/conflicts: Medium-high for HAS role/access caveats; current reassessment status beyond page should be refreshed later.
- dose-intensive B-ALL/GMALL-style protocols; CODOX-M/IVAC; DA-EPOCH-R for selected patients unable to receive B-ALL protocol[34]Standard option (per Onkopedia / DGHO-associated guideline platform)HIV-associated lymphoma context; MYC-translocation diagnostic context from ALL differential guidance; HIV-associated Burkitt lymphoma; first-line intensive curative-intent regimen selection, with DA-EPOCH-R discussed when B-ALL protocol is not feasible. · German-language guideline; translation/human review needed before patient-facing reuse. The source describes regimen classes and outcomes, not an individual eligibility decision, dosing instructions, or guaranteed access. Burkitt leukemia/lymphoma diagnosis should be distinguished from B-precursor ALL using immunophenotype and molecular findings. Confidence/conflicts: Medium-high for Germany guideline context; exact reimbursement/protocol availability remains center-specific. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
- epcoritamab (Tepkinly)[25]EMA authorisedCD20xCD3 bispecific antibody context; Adult R/R FL after two or more lines of systemic therapy. · IQWiG assessment is part of the German HTA process; current final G-BA resolution should be checked for the legally binding decision. EMA central authorization does not determine German negotiated reimbursement details. Confidence/conflicts: Medium-high; EMA confirms EU indication while IQWiG reports added benefit not proven in German HTA. No contradiction about authorization versus added-benefit assessment.
- glofitamab (Columvi) monotherapy[35]ApprovedCD20xCD3 bispecific antibody context; Adults with R/R DLBCL after two or more systemic therapy lines. · G-BA PDF is a courtesy translation and notes that only the German version is legally binding; it also states the resolution has been repealed. IQWiG assessment is not the final G-BA decision and notes that G-BA commenting may modify the result. This entry records the conflict/sequence rather than smoothing it. Confidence/conflicts: Medium-high for German HTA sequence; explicit source conflict/sequence between repealed orphan-resolution framing and newer IQWiG reassessment noted. Final current G-BA decision remains a follow-up gap.
- glofitamab (Columvi) with gemcitabine and oxaliplatin[36]HAS reimbursement opinionCD20xCD3 bispecific antibody context; Adult R/R DLBCL NOS, ineligible for autologous stem-cell transplant, in combination with gemcitabine and oxaliplatin. · HAS notes limitations including exploratory quality-of-life data, indirect-comparison limits regarding the role of glofitamab in CAR-T-eligible patients, and a safety profile marked by cytokine-release syndrome. This is an HTA reimbursement opinion, not a personalized eligibility determination. Confidence/conflicts: High for HAS reimbursement opinion summary and caveats. No conflict identified.
- mosunetuzumab (Lunsumio)[37]ApprovedCD20xCD3 bispecific antibody context; Adult R/R FL after at least two prior systemic therapies. · Courtesy translation only; German version is legally binding. The source states treatment should be initiated and monitored by hematology/oncology specialists experienced in FL and administered in a setting equipped to manage severe reactions such as cytokine release syndrome. It also notes approval under special conditions and that grade 3b FL was not investigated in the dose-expansion phase of GO29781. Confidence/conflicts: High for German HTA indication and caveats; no conflict identified.
- mosunetuzumab (Lunsumio)[38]ApprovedCD20xCD3 bispecific antibody context; Adult R/R FL after at least two prior systemic therapies. · This is French reimbursement/HTA status, not EU marketing authorization. HAS cited absence of robust data sufficient to demonstrate efficacy and quantify effect in the marketing-authorization indication from the available non-comparative study data. Current availability should be rechecked because the opinion was posted in 2023. Confidence/conflicts: High for HAS reimbursement opinion; stale-current-refresh-needed. No conflict identified.
- nivolumab (Opdivo)[39]ApprovedPD-1 checkpoint inhibitor context; Adult relapsed or refractory cHL after ASCT and brentuximab vedotin. · German-language G-BA source requires legal-language review. The page records assessment process and label indication but final additional-benefit details require the decision PDF. Confidence/conflicts: Medium-high for German assessment/label scope; exact additional-benefit conclusion needs decision PDF review. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
- nivolumab (Opdivo) with doxorubicin, vinblastine, and dacarbazine (AVD)[40]ApprovedPD-1 checkpoint inhibitor context; no biomarker restriction in fetched source; Previously untreated advanced classical Hodgkin lymphoma in the EU. · This is a company press release; EMA product information and member-state reimbursement should be checked. Germany, France, and other EU countries may differ in HTA and access timing. Confidence/conflicts: Medium-high for EU approval signal; EMA product-info and national reimbursement remain gaps. No conflict identified.
- pirtobrutinib (Jaypirca)[41]ApprovedBTK inhibitor prior-treatment context; Adult R/R MCL after at least one prior BTK inhibitor therapy. · The G-BA resolution is a German statutory health-insurance benefit-assessment document, not an individual access guarantee. The English PDF is a courtesy translation; the German version is legally binding. G-BA notes conditional marketing authorisation and that treatment should be initiated and monitored by specialists experienced in MCL. Confidence/conflicts: High for G-BA HTA conclusion and indication scope. No conflict identified.
- pirtobrutinib (Jaypirca)[42]ApprovedBTK inhibitor prior-treatment context; Tecartus-ineligible context; Third-line-or-later alternative for adult R/R MCL after BTK inhibitor when Tecartus is not an option, as described by HAS. · HAS rates the clinical benefit as low in the favorable scope and insufficient outside it, with no clinical added value (CAV V). Maintenance of low clinical benefit is conditional on reassessment within two years based on additional data. Eligibility for Tecartus-ineligible status and French reimbursement implementation require treating-team and payer confirmation. Confidence/conflicts: High for HAS reimbursement scope; no conflict identified.
- polatuzumab vedotin (Polivy) with bendamustine and rituximab[43]EMA authorisedCD79b-targeted antibody-drug conjugate context; Adult R/R DLBCL not candidates for hematopoietic stem-cell transplant. · This is German benefit-assessment context, not a statement that the medicine is unavailable. The courtesy translation says the German version is legally binding. Access depends on the current German reimbursement and prescribing setting. Confidence/conflicts: High for German HTA conclusion and indication scope. No conflict identified.
- polatuzumab vedotin (Polivy) with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP)[44]ApprovedCD79b-targeted antibody-drug conjugate context; Previously untreated adult DLBCL. · This is a French reimbursement/HTA opinion, not a denial of European marketing authorization. HAS also notes the first-line treatment framework with anti-CD20 chemoimmunotherapy such as R-CHOP. Recheck current HAS updates before surfacing as current availability. Confidence/conflicts: Medium-high; HAS opinion is older than 12 months and should be refreshed for current reimbursement before patient-facing display. No direct conflict identified in fetched sources.
- teclistamab (Tecvayli)[45]ApprovedBCMA x CD3 bispecific antibody context; Adult relapsed/refractory myeloma after at least three prior therapies including IMiD, PI, and anti-CD38 antibody. · This German HTA conclusion does not withdraw the EMA-approved indication; it states the additional benefit versus comparator therapy was not proven from the submitted single-arm data. G-BA also notes conditional marketing authorisation and CRS risk-minimisation materials. Confidence/conflicts: High for German HTA conclusion; no conflict identified, but approval and added-benefit conclusion differ.
- teclistamab (Tecvayli)[46]ApprovedBCMA x CD3 bispecific antibody context; Adult relapsed/refractory myeloma after at least three prior therapies including IMiD, PI, and anti-CD38 antibody. · A favourable reimbursement opinion is not a claim of superiority. HAS explicitly assigns CAV V and notes pending randomized evidence. French implementation and hospital access still require local confirmation. Confidence/conflicts: High for France HAS reimbursement opinion and CAV V caveat. No conflict identified.
- tisagenlecleucel (Kymriah)[47]EMA authorisedCD19-directed CAR-T context; Adult FL after at least two therapy lines, restricted to refractory disease, relapse during/within six months after maintenance, or relapse after autologous transplant in the HAS reimbursement scope. · HAS states no improvement in clinical added value (ASMR V) in the reimbursed scope and notes uncertainties from non-comparative phase 2 evidence, short/medium-term toxicity, and longer-term efficacy/safety. CAR-T access depends on multidisciplinary review, center capacity, manufacturing, and current payer rules. Confidence/conflicts: High for HAS reimbursement scope; stale-current-refresh-needed given 2022 opinion. No conflict identified.
United Kingdom
- Bortezomib induction or relapse monotherapy contexts; thalidomide with alkylating agent and corticosteroid; lenalidomide plus dexamethasone; second autologous stem cell transplant in selected relapsed contexts; teclistamab (Tecvayli); supportive/complication management including radiotherapy, surgery/stabilisation, vaccination, IVIG in recurrent infections with hypogammaglobulinaemia, antiviral prophylaxis contexts, and symptom-directed imaging[48]NICE recommendedBCMA relevant to teclistamab; no mutation biomarker stated; Newly diagnosed myeloma; transplant-eligible and transplant-ineligible contexts; first relapse; selected second autologous SCT after relapse; subsequent therapy after at least two prior therapies; relapsed/refractory after at least three lines for teclistamab. · NICE guidance is England-context unless otherwise specified and does not establish Scotland, Wales, or Northern Ireland access. Several NG35 recommendations are inherited from older technology appraisals and should be checked against current commissioning and medicine-specific appraisals. Teclistamab with daratumumab is not yet a NICE recommendation in the fetched source. Confidence/conflicts: High for NICE England-context recommendations and in-development status; no conflict identified.
- Brentuximab vedotin (Adcetris) plus doxorubicin, dacarbazine, and vinblastine; brentuximab vedotin monotherapy; nivolumab (Opdivo); pembrolizumab (Keytruda)[4]ApprovedCD30-positive for brentuximab vedotin recommendations; no mutation biomarker stated for nivolumab or pembrolizumab recommendations; Untreated stage 3 or 4 CD30-positive Hodgkin lymphoma in adults; relapsed/refractory cHL after ASCT and brentuximab vedotin; relapsed/refractory cHL age 3+ after at least two prior treatments when ASCT is not an option; relapsed/refractory CD30-positive Hodgkin lymphoma after ASCT or when ASCT/multiagent chemotherapy are not suitable after at least two therapies. · NICE technology appraisal guidance is England/NHS-context and includes commercial-arrangement and stopping-rule conditions. It does not establish access in all devolved UK nations, individual eligibility, transplant suitability, or sequencing preference. Confidence/conflicts: High for NICE England recommendation wording; nivolumab with AVD and nivolumab-brentuximab appraisals are in development/suspended and are not recorded here as recommendations.
- Chemotherapy plus rituximab; cytarabine-containing immunochemotherapy; radiotherapy; observation/watch and wait; bortezomib (Velcade); autologous stem cell transplant consolidation; rituximab maintenance; zanubrutinib (Brukinsa); ibrutinib (Imbruvica); brexucabtagene autoleucel (Tecartus)[49]EMA authorisedCD20 relevant to rituximab-containing regimens; CD19 relevant to brexucabtagene autoleucel; BTK inhibitor prior exposure relevant to brexucabtagene autoleucel post-BTK setting; no mutation biomarker stated; First-line advanced symptomatic; fit-for-intensive advanced MCL; localised stage 1 or 2; clinically non-progressive asymptomatic disease; previously untreated transplant-unsuitable; chemosensitive consolidation after induction; newly diagnosed response/remission maintenance; relapsed/refractory after one prior line for ibrutinib/zanubrutinib; relapsed/refractory post-BTK inhibitor for brexucabtagene autoleucel. · NICE guidance applies to England unless otherwise stated and does not establish Scotland, Wales, or Northern Ireland access. NICE notes rituximab and cytarabine uses were off-label in June 2026 in the guideline contexts. Several drug recommendations include commercial arrangements or Cancer Drugs Fund managed-access conditions. Confidence/conflicts: High for NICE England-context recommendations. Note possible future change risk around brexucabtagene autoleucel because external news indicates reconsideration activity in June 2026, but only the fetched NICE TA677 recommendation is recorded here.
- Epcoritamab (Tepkinly)[50]NICE recommendedNo molecular biomarker restriction stated in the NICE recommendation; prior polatuzumab exposure or contraindication/intolerance is the access qualifier.; Relapsed or refractory adult DLBCL after 2 or more systemic treatments, with prior-polivy or Polivy-unsuitable condition. · This is an England NHS appraisal condition, not a general UK access statement. The page does not establish local center sequencing or devolved-nation availability. Confidence/conflicts: High for England recommendation wording.
- Glofitamab (Columvi)[51]ApprovedNo molecular biomarker restriction stated in the NICE recommendation.; Relapsed or refractory adult DLBCL after 2 or more systemic treatments. · This is an England NHS recommendation and does not establish access in Scotland, Wales, or Northern Ireland. The source does not by itself resolve treatment sequencing versus CAR-T or other later-line options at an individual center. Confidence/conflicts: High for England recommendation wording.
- Glofitamab plus gemcitabine and oxaliplatin[52]NICE recommendedNo molecular biomarker restriction stated in the NICE recommendation; transplant ineligibility and treatment-line count define the NHS use.; Second-line relapsed or refractory adult DLBCL NOS after 1 prior treatment line, autologous-transplant-ineligible. · NICE explicitly evaluated this narrower NHS-use population rather than everyone within the licensed indication. This is an England NHS recommendation and should not be generalized to all UK jurisdictions. Confidence/conflicts: High for England recommendation wording.
- Intensive immunochemotherapy; R-BFM; R-CODOX-M/R-IVAC; R-HyperCVAD with high-dose methotrexate; R-LMB; DA-EPOCH-R with intravenous methotrexate and/or intrathecal methotrexate for low-risk disease; less intensive R-CHOP, R-CHEOP, or DA-EPOCH-R with or without intravenous and/or intrathecal methotrexate in patients not fit for intensive chemotherapy[49]NICE recommendedCD20 implied by rituximab-containing regimens; no mutation biomarker stated; First-line Burkitt lymphoma; low-risk Burkitt lymphoma; patients not fit enough for intensive chemotherapy. · NICE guidance applies to England unless otherwise stated and does not establish Scotland, Wales, or Northern Ireland access. Regimen selection and exact components require specialist protocol confirmation. This finding does not establish medicine-specific MHRA labels. Confidence/conflicts: High for NICE England-context recommendations; no conflict identified.
- Local radiotherapy; observation/watch and wait; rituximab; rituximab plus chemotherapy; rituximab maintenance; obinutuzumab plus chemotherapy followed by maintenance; obinutuzumab plus bendamustine followed by maintenance; lenalidomide plus rituximab; epcoritamab (Tepkinly); lisocabtagene maraleucel for large B-cell lymphoma including follicular lymphoma grade 3B context; autologous or allogeneic stem cell transplantation consolidation in specified remission/transformation contexts; mosunetuzumab (Lunsumio) not recommended; axicabtagene ciloleucel (Yescarta) not recommended for relapsed/refractory follicular lymphoma in its appraised setting[49]ApprovedCD20 relevant to rituximab, obinutuzumab, mosunetuzumab, and epcoritamab contexts; CD3 relevant to bispecific antibody mechanisms; CD19 relevant to CAR T-cell therapy; no mutation biomarker stated; First-line localised stage 2A; advanced asymptomatic; untreated stage 3 or 4/advanced symptomatic; untreated advanced FLIPI score 2 or more; rituximab-refractory or early-progressing after rituximab-containing regimen; previously treated grade 1 to 3A; relapsed/refractory after two or more systemic treatments; relapsed/refractory after three or more systemic treatments for axicabtagene ciloleucel negative appraisal; second/subsequent remission or transformed follicular lymphoma transplant consolidation contexts. · NICE guidance applies to England unless otherwise stated and does not establish Scotland, Wales, or Northern Ireland access. Commercial arrangements and stopping rules are part of several positive recommendations. Negative NICE recommendations for mosunetuzumab and axicabtagene ciloleucel are availability signals, not statements that the medicines lack biological activity. NICE notes rituximab induction for advanced asymptomatic follicular lymphoma was off-label in June 2026. Confidence/conflicts: High for NICE England-context recommendations. Apparent conflict with EU authorisation is jurisdictional, not evidentiary: EMA authorisation does not guarantee routine NHS funding in England, and NICE explicitly does not recommend mosunetuzumab or axicabtagene ciloleucel in the appraised follicular lymphoma settings.
- Loncastuximab tesirine[53]NICE recommendedNo molecular biomarker restriction stated in the NICE recommendation; prior polatuzumab exposure or contraindication/intolerance is the access qualifier.; Relapsed or refractory adult DLBCL or HGBL after 2 or more systemic treatments, with prior-polivy or Polivy-unsuitable condition. · This is an England NHS appraisal recommendation and does not establish access outside England. It also does not establish center-specific sequencing relative to CAR-T or bispecific antibodies. Confidence/conflicts: High for England recommendation wording.
- Polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin and prednisolone (Pola-R-CHP)[54]NICE recommendedInternational Prognostic Index (IPI) score 2 to 5; no molecular biomarker restriction stated in the NICE recommendation.; First-line treatment for untreated adult DLBCL with IPI 2 to 5. · This is an England NHS appraisal recommendation, not a general UK-wide access statement. NICE notes the recommendation is narrower than the marketing authorisation because that is the population supported for NHS use in the appraisal. Confidence/conflicts: High for England recommendation wording; no devolved-UK or MHRA inference made.
- Polatuzumab vedotin with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP); glofitamab plus gemcitabine and oxaliplatin; loncastuximab tesirine; axicabtagene ciloleucel (Yescarta); epcoritamab (Tepkinly); glofitamab (Columvi); tafasitamab plus lenalidomide (not recommended in TA883)[54]NICE recommendedCD19 CAR T-cell context for axicabtagene ciloleucel; CD20xCD3 bispecific context for epcoritamab/glofitamab; CD79b-targeted polatuzumab context; no mutation biomarker stated in captured NICE recommendation text; Untreated DLBCL with IPI 2 to 5; relapsed/refractory DLBCL after one line and ASCT-ineligible for glofitamab-gemcitabine-oxaliplatin; relapsed/refractory DLBCL or HGBL after two or more systemic treatments for loncastuximab and overview-cited bispecific/CAR T appraisals; tafasitamab-lenalidomide negative appraisal in transplant-ineligible relapsed/refractory DLBCL. · NICE technology appraisal guidance is England/NHS-context and includes commercial-arrangement conditions. Several NICE recommendation chapter URLs returned server errors during this cycle, so overview pages were used for TA872, TA927, and TA954 and the exact recommendation-text refresh remains a gap. This does not establish access in devolved UK nations, individual eligibility, CAR T center capacity, or sequencing priority. Confidence/conflicts: Medium-high; direct recommendation text is high for TA874, TA1113, TA947, and TA883, while TA872/TA927/TA954 exact recommendation chapter refresh remains pending because NICE returned server errors for those chapter URLs.
- Zanubrutinib (Brukinsa); ibrutinib (Imbruvica); bendamustine plus rituximab; dexamethasone-rituximab-cyclophosphamide, rituximab alone, chlorambucil alone as comparator/context therapies[55]ApprovedNICE final-scope background mentions MYD88 mutation prevalence, but recommendation text is not biomarker-restricted; Adults with previously treated WM for both TA833 and TA795; NICE TA833 does not recommend first-line zanubrutinib for chemoimmunotherapy-unsuitable disease because cost-effectiveness estimates were above NICE's usual range. · NICE technology appraisals apply to England unless otherwise specified and include commercial-arrangement or funding-transition conditions. Scotland, Wales, and Northern Ireland decisions are separate. Confidence/conflicts: High for NICE England-context recommendations. Apparent jurisdictional difference recorded: EMA lists ibrutinib for WM, while NICE TA795 does not recommend it for NHS England use in the stated context.
- bisphosphonate therapy, denosumab consideration, cement augmentation, radiotherapy, and orthopedic/surgical interventions for selected complications[56]Standard option (per NSSG / Oxford Haematology)not biomarker-specific; Symptomatic multiple myeloma bone protection and complication management; renal-impairment and pain/fracture contexts. · UK regional protocols may not apply outside the local NHS area and funding arrangements can differ. This is supportive-care pathway information, not a personalized recommendation. Confidence/conflicts: Medium-high for UK regional supportive-care pathways; local funding and hospital protocols may differ. No conflict identified.
- brentuximab vedotin (Adcetris)[57]NICE recommendedCD30-positive Hodgkin lymphoma; Adult relapsed or refractory CD30-positive Hodgkin lymphoma; recommendation details depend on prior ASCT and prior-therapy suitability. · Exact eligibility is in the recommendation section and commercial arrangement; local NHS implementation should be confirmed. Not a statement of individual suitability. Confidence/conflicts: High for England NICE overview; no conflict identified.
- brentuximab vedotin (Adcetris) in combination therapy[58]NICE recommendedCD30-positive Hodgkin lymphoma; Adult untreated stage 3 or 4 CD30-positive Hodgkin lymphoma. · NICE England guidance is not automatically identical to Scotland, Wales, or Northern Ireland implementation. Exact regimen and funding terms should be confirmed through local NHS pathways and the final recommendation section. Confidence/conflicts: High for England NICE overview; implementation outside England remains a gap. No conflict identified.
- nivolumab (Opdivo)[59]NICE recommendedPD-1 checkpoint inhibitor context; Adult relapsed or refractory classical Hodgkin lymphoma. · Guidance is older and should be checked against current NHS commissioning, updated labels, and newer frontline nivolumab-AVD developments. This is England-context NICE guidance. Confidence/conflicts: High for England NICE overview; stale-guidance caveat applies. No conflict identified.
- pembrolizumab (Keytruda)[60]NICE recommendedPD-1 checkpoint inhibitor context; Relapsed or refractory classical Hodgkin lymphoma in people age 3 years and over. · NICE guidance partially updates prior TA540; local implementation and exact previous-treatment criteria should be checked in the recommendation section. This entry does not establish access in Scotland, Wales, or Northern Ireland. Confidence/conflicts: High for England NICE overview; no conflict identified.
Japan
- Acalabrutinib (Calquence); pirtobrutinib (Jaypirca); venetoclax (Venclexta); ibrutinib (Imbruvica); bendamustine (Treakisym); bortezomib (Velcade); cladribine (Leustatin); ibritumomab tiuxetan with yttrium-90/indium-111 (Zevalin set); fludarabine (Fludara)[61]PMDA-approved (Japan)BTK inhibitor resistance or intolerance relevant to pirtobrutinib; no mutation biomarker stated; Mantle cell lymphoma for Calquence/Imbruvica/Velcade; relapsed or refractory MCL with resistance or intolerance to other BTK inhibitors for Jaypirca; relapsed or refractory MCL for Venclexta and Imbruvica historical entry; recurrent/relapsing/refractory indolent B-cell NHL including MCL for Leustatin; relapsed/refractory CD20-positive low-grade B-cell NHL and MCL for Zevalin set; low-grade B-cell NHL and mantle-cell lymphoma context for Fludara. · PMDA's approved-drug list verifies approval-list entries but not current Japanese package-insert restrictions, reimbursement, availability, dosing, sequencing, or individual eligibility. CAR T-cell product-specific MCL status was not verified from this PMDA list scan and remains a Japan gap. Confidence/conflicts: Medium-high for Japan approval-list presence; lower for current practical access because package inserts, reimbursement, and regenerative-medicine/CAR T sources were not fetched.
- Brentuximab vedotin (Adcetris); nivolumab (Opdivo); pembrolizumab (Keytruda)[61]PMDA-approved (Japan)CD30-positive context for brentuximab vedotin; no mutation biomarker stated for nivolumab or pembrolizumab PMDA list entries; Relapsed/refractory CD30-positive Hodgkin lymphoma for brentuximab vedotin; CD30-positive Hodgkin lymphoma indication/dosage change and pediatric dosage contexts for brentuximab vedotin; relapsed/refractory classical Hodgkin lymphoma for nivolumab and pembrolizumab, including pediatric dosage context for nivolumab. · The PMDA list verifies approval-list history and broad indication wording, not current package-insert details, reimbursement, institutional access, combination rules, or individual suitability. Confidence/conflicts: High for PMDA approval-list wording; current Japanese package inserts and reimbursement remain active gaps.
- Epcoritamab (Epkinly); polatuzumab vedotin (Polivy); bendamustine hydrochloride[61]PMDA-approved (Japan)CD20xCD3 bispecific context for epcoritamab; CD79b antibody-drug conjugate context for polatuzumab vedotin; no mutation biomarker stated in the captured PMDA approved-drug list entries; Relapsed/refractory large B-cell lymphoma for epcoritamab; relapsed/refractory DLBCL and DLBCL indication/dosage expansion contexts for polatuzumab vedotin; relapsed/refractory DLBCL context for bendamustine. · The PMDA list verifies approval-list history and broad indication wording, not current package-insert details, reimbursement, treatment combinations, CAR T-cell availability, or individual eligibility. Confidence/conflicts: High for PMDA approval-list wording; CAR T-cell product-specific Japan DLBCL checks remain source-pending from this source class.
- Mosunetuzumab (Lunsumio); epcoritamab (Epkinly); lenalidomide hydrate (Revlimid); obinutuzumab (Gazyva); cladribine (Leustatin)[61]PMDA-approved (Japan)EZH2 gene mutation-positive context for tazemetostat; CD20-positive context for obinutuzumab; CD20/CD3 relevant to bispecific antibodies; no mutation biomarker stated for lenalidomide, mosunetuzumab, epcoritamab, or cladribine entries; Relapsed or refractory follicular lymphoma for Lunsumio, Epkinly, Revlimid, and Tazverik; Tazverik specifically EZH2 gene mutation-positive and only if refractory or intolerant to standard therapies; CD20-positive follicular lymphoma for Gazyva; recurrent, relapsing, or refractory indolent B-cell NHL including follicular lymphoma for Leustatin. · PMDA's approved-drug list verifies approval-list status but not current Japanese package-insert details, reimbursement, institutional access, line-by-line sequencing, dosing, or individual eligibility. U.S. FDA withdrawal of tazemetostat is not automatically a Japan regulatory action; this Japan finding records only the PMDA list entry and should be refreshed against current Japanese label/safety communications. Confidence/conflicts: Medium-high for Japan approval-list presence and stated indications. Confidence is lower for current practical availability because package inserts, reimbursement, and current local safety communications were not fetched.
- axicabtagene ciloleucel (Yescarta)[62]ApprovedCD19-directed CAR-T context; Japan relapsed/refractory LBCL, including second-line initial relapsed/refractory treatment and later-line contexts in company announcement. · Company source; direct PMDA package insert/review report should be fetched for exact current label and conditions. CAR-T center, manufacturing, toxicity management, and reimbursement must be confirmed. Confidence/conflicts: Medium-high for Japan approval signal; direct PMDA label remains a gap. No conflict identified. A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
- belantamab mafodotin (Blenrep) with bortezomib-dexamethasone or with pomalidomide-dexamethasone[63]ApprovedBCMA-targeted antibody-drug conjugate context; Adult relapsed or refractory multiple myeloma; the press release describes activity as early as first relapse and cites combination approval. · This is a company report of MHLW approval, not a directly fetched MHLW/PMDA label. Belantamab mafodotin has important ocular toxicity monitoring in other jurisdictions; Japan-specific package-insert, ophthalmic monitoring, NHI price, and access details require direct verification. Confidence/conflicts: Medium-high for Japan MHLW approval signal via company source; direct label/NHI details remain gaps. 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.
- brentuximab vedotin (Adcetris)[64]ApprovedCD30-positive Hodgkin lymphoma; Japan approval signal for relapsed/refractory HL, untreated HL with AVD, and pediatric dosage/administration context; exact current package insert should be fetched. · This is a company summary embedded in a China press release, not a PMDA package insert. Direct PMDA label and reimbursement remain active gaps. Confidence/conflicts: Medium for Japan approval signal; direct PMDA verification needed. No conflict identified. A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
- ciltacabtagene autoleucel (Carvykti)[65]PMDA-approved (Japan)BCMA-targeted CAR T-cell therapy context; Relapsed or refractory multiple myeloma; the review report context includes heavily pretreated patients with prior proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody exposure. · This PMDA review confirms approval-review basis but does not provide current NHI price, current package-insert changes, or current CAR-T center availability. Manufacturing, bridging, and toxicity monitoring require qualified-center discussion. Confidence/conflicts: High for Japan PMDA approval-review context; current insert/NHI/center availability remain gaps. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- daratumumab (Darzalex) plus melphalan, prednisone, and bortezomib/MPB[66]PMDA-approved (Japan)CD38-targeted monoclonal antibody context; Previously untreated multiple myeloma ineligible for autologous stem cell transplantation. · PMDA notes the study population was transplant-ineligible and that daratumumab/MPB was not recommended for transplant-eligible untreated patients based on absence of study data in that population. Current package insert and reimbursement details remain separate checks. Confidence/conflicts: High for Japan PMDA review conclusion in transplant-ineligible untreated MM; current package insert/NHI details remain gaps. No conflict identified.
- daratumumab (Darzalex) with lenalidomide-dexamethasone or bortezomib-dexamethasone; monotherapy caveat[67]PMDA-approved (Japan)CD38-targeted monoclonal antibody context; Relapsed or refractory multiple myeloma combination-treatment context. · The review supports combination use in R/R MM and explicitly cautions against monotherapy in that review context. Current label evolution, subcutaneous formulation access, and reimbursement should be refreshed separately. Confidence/conflicts: Medium-high for PMDA R/R MM combination-positioning; current label may have evolved and should be refreshed. No conflict identified.
- elranatamab (Elrexfio)[68]ApprovedBCMA-targeted bispecific antibody context; Relapsed or refractory multiple myeloma; standard-treatment-difficult wording from Kusuri-no-Shiori. · Kusuri-no-Shiori is a patient drug-information source, not the PMDA review report. The Japan approval date is from peer-reviewed secondary literature, not direct PMDA/MHLW source. Current Japanese label, NHI listing, and institution-specific access require direct verification. Confidence/conflicts: Medium for current Japan approval/access signal because direct PMDA/MHLW label was not fetched; high for existence of Japanese drug-information page. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- ibrutinib (Imbruvica) with bendamustine and rituximab context[69]PMDA-approved (Japan)BTK inhibitor therapy context; Treatment-naive MCL; review report notes the pivotal Study 3002 targeted treatment-naive MCL age 65 or older at Ann Arbor stage II-IV, and highlights caution where efficacy/safety are not established for intensive-chemotherapy-eligible patients or stage I treatment-naive MCL. · PMDA review report is a regulatory assessment, not a patient-specific recommendation. Current package insert, NHI listing, and center practice should be checked; treatment selection must account for PMDA-noted safety concerns and the study population limitations. Confidence/conflicts: High for PMDA review conclusion and cautions. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- idecabtagene vicleucel (Abecma)[70]PMDA-approved (Japan)BCMA-targeted CAR T-cell therapy context; Relapsed/refractory multiple myeloma; initial Japan approval after at least three prior lines, with partial-change review for at least two prior lines. · This PMDA review report confirms the prior approval and review context, but final current package insert, NHI listing, and CAR-T center availability should be checked before surfacing as current access. Confidence/conflicts: Medium-high for Japan PMDA approval/review context; current label and NHI access remain refresh gaps. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- lisocabtagene maraleucel (Breyanzi)[71]PMDA-approved (Japan)CD19-positive CAR-T context; product intended only for patients without prior CD19-targeted CAR-positive T-cell infusion per PMDA text; Japan relapsed/refractory LBCL including DLBCL after at least one prior line in current PMDA context; earlier third-line-plus approval noted. · PMDA English translation is for reference and Japanese original takes precedence. CAR-T access depends on certified center capability, leukapheresis/manufacturing, toxicity management, and payer rules. Confidence/conflicts: High for PMDA indication/performance text; Japanese original legal text takes precedence. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- mosunetuzumab (Lunsumio)[72]ApprovedCD20xCD3 bispecific antibody context; Japan R/R FL after two or more prior standard therapies; label precautions specify anti-CD20 monoclonal antibody exposure and grade 1-3A diagnosis by an experienced pathologist. · Company launch announcement; direct PMDA/MHLW package insert should be checked for legally controlling wording. The source does include NHI price-list date and launch date, but individual access still depends on center eligibility and payer implementation. Confidence/conflicts: Medium-high for Japan approval/NHI launch signal; direct PMDA/MHLW insert remains a follow-up gap. No conflict identified. A secondary/company source is present; the cited primary source is the regulator/HTA/official record.
- pirtobrutinib (Jaypirca)[73]PMDA-approved (Japan)BTK inhibitor resistance or intolerance context; Japan R/R MCL resistant or intolerant to other BTK inhibitors. · PMDA review report and company announcement establish approval; current NHI price listing, site-specific formulary availability, and patient-specific reimbursement were not verified in this cell. Treatment should be discussed with hematology specialists familiar with the package insert and risk-management requirements. Confidence/conflicts: High for approval scope; reimbursement/formulary gap remains. No conflict identified.
- rituximab (Rituxan)[74]PMDA-approved (Japan)CD20-positive B-cell lymphoma; CD20-positive B-cell NHL; Burkitt lymphoma is captured here as a CD20-positive mature B-cell NHL context when confirmed by the treating team, but the fetched PMDA wording is not Burkitt-specific. · The PMDA source supports a broad CD20-positive B-cell NHL authorization, not a Burkitt-only protocol. Burkitt lymphoma treatment in Japan should be confirmed against pediatric/adult oncology protocols, package insert wording, payer rules, and center-specific chemotherapy pathways. Confidence/conflicts: Medium-high for broad Japan CD20-positive B-cell NHL approval; Burkitt-specific protocol/reimbursement detail remains a gap. No conflict identified.
- tazemetostat hydrobromide (Tazverik)[75]Withdrawn / discontinued in Japan (Mar 2026)EZH2 gene mutation-positive context for tazemetostat; CD20-positive context for obinutuzumab; CD20/CD3 relevant to bispecific antibodies; no mutation biomarker stated for lenalidomide, mosunetuzumab, epcoritamab, or cladribine entries; Relapsed or refractory follicular lymphoma for Lunsumio, Epkinly, Revlimid, and Tazverik; Tazverik specifically EZH2 gene mutation-positive and only if refractory or intolerant to standard therapies; CD20-positive follicular lymphoma for Gazyva; recurrent, relapsing, or refractory indolent B-cell NHL including follicular lymphoma for Leustatin. · Tazverik (tazemetostat) was voluntarily withdrawn/discontinued in Japan by marketing-authorisation holder Eisai on 19 March 2026 — physicians instructed to stop current patients and start none — following Ipsen's 9 March 2026 global withdrawal of all indications over secondary hematologic malignancies (SYMPHONY-1). It is NOT a current/approved/available option. The other drugs in this bundle (mosunetuzumab, epcoritamab, lenalidomide, obinutuzumab, cladribine) are unaffected and remain valid.
Korea
- axicabtagene ciloleucel (Yescarta / 예스카타주)[76]ApprovedCD19-directed CAR-T context; Adult relapsed/refractory DLBCL or PMBCL after two or more systemic therapy lines; second-line early relapse/refractory DLBCL reimbursement criteria not set in the January 2026 CDRC result. · Korean-language payer source; human review needed. HIRA notes subsequent process steps and that final details may change during later reimbursement procedures. This finding records payer review status, not individual eligibility or site availability. Confidence/conflicts: High for HIRA review outcomes; exact final listed reimbursement implementation should be checked in current NHIS/HIRA listing. No source conflict identified. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
- daratumumab (Darzalex SC)[77]ApprovedCD38-targeted monoclonal antibody context; Multiple myeloma reimbursement-applications context across newly diagnosed and relapsed/refractory settings. · This is a HIRA reimbursement-criteria decision page, not an MFDS approval label. It records that reimbursement criteria were not established for the listed MM applications at that committee meeting; later NHIS/HIRA changes require refresh. Confidence/conflicts: High for HIRA committee outcome as of the fetched page; MFDS label and later final listing notices remain gaps. No conflict identified.
- elranatamab (Elrexfio)[78]ApprovedBCMA-targeted bispecific antibody context; prior PI, IMiD, and anti-CD38 exposure; Adult relapsed or refractory multiple myeloma after at least third-line or later therapy including PI, IMiD, and anti-CD38 monoclonal antibody. · Korean-language HIRA committee source requires human review. Criteria-setting does not automatically confirm final drug-price listing, hospital availability, or exact MFDS-approved label. Confidence/conflicts: High for HIRA committee criteria-setting signal; final NHIS implementation and MFDS label remain gaps. No conflict identified. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
- mosunetuzumab (Lunsumio)[79]MFDS-approved (Korea)CD20xCD3 bispecific antibody context; Adult R/R FL after two or more lines of systemic therapy. · Secondary English-language Korean pharmaceutical-news source; direct MFDS label and HIRA reimbursement listing remain gaps. Approval does not establish payer coverage or hospital formulary access. Confidence/conflicts: Medium-high for Korea approval signal; direct MFDS/HIRA documentation remains a follow-up gap. No conflict identified.
- pirtobrutinib (Jaypirca)[80]ApprovedBTK inhibitor prior-treatment context; Adult R/R MCL after at least two prior therapies including a BTK inhibitor, per Korea Biomedical Review's report of the HIRA notice. · HIRA's English press-release page confirms reimbursement adequacy for R/R MCL but does not show the full final reimbursement criteria or price-negotiation details. The effective national-insurance date and two-prior-therapy/prior-BTK scope come from a Korean medical-news report citing HIRA and Lilly Korea. Direct MFDS label and final reimbursement notification remain follow-up gaps. Confidence/conflicts: Medium-high for reimbursement signal and likely effective listing; direct MFDS label and final HIRA/NHIS criteria remain gaps. No conflict identified.
- polatuzumab vedotin (Polivy / 폴라이비주) with rituximab, cyclophosphamide, doxorubicin, and prednisone/prednisolone (R-CHP)[81]ApprovedCD79b-targeted antibody-drug conjugate context; Adults with previously untreated DLBCL, in combination with R-CHP. · Korean-language payer source; human review needed. HIRA states that detailed reimbursement scope may differ from the product indication and that final results can change if product standards, requested product details, label changes, or authorization status change. The source does not establish individual eligibility. Confidence/conflicts: High for HIRA assessment result; final implementation/listing remains a follow-up gap. No source conflict identified. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
- rituximab plus hyper-CVAD (R-hyper-CVAD)[82]Standard option (per Korea Citation Index / Cancer Research and Treatment)CD20-directed treatment context when rituximab is used; First-line adult sporadic Burkitt or Burkitt-like lymphoma study context in Korea. · This is older multicenter evidence and not a current national guideline, drug label, or payer rule. The study conclusion on the KCI page emphasizes suitability for dose-intense chemotherapy and notes difficulty for patients intolerant to dose-intensive treatment because of treatment-related complications. Confidence/conflicts: Medium for Korean multicenter historical practice evidence; no regulator/payer claim made. No conflict identified.
- rituximab plus hyper-CVAD/MC or rituximab plus CHOP in selected older/poor-performance-status patients[83]Standard option (per Frontiers in Oncology / Catholic University of Korea authors)MYC-driven B-cell NHL context; CD20-directed treatment context when rituximab is used; Adult Burkitt lymphoma first-line routine-care evidence context; the article is observational and does not establish an MFDS label or HIRA reimbursement criterion. · This source is peer-reviewed Korean real-world evidence, not a regulator or payer document. It supports documented Korean practice patterns and outcomes discussion, not individual eligibility, superiority, or national coverage. The article explicitly notes no optimal strategy has been established. Confidence/conflicts: Medium for Korea practice-context evidence; current MFDS/HIRA label and reimbursement details remain gaps. No conflict identified.
- selinexor (XPOVIO) for adult R/R MM[84]ApprovedXPO1 inhibitor context; Adult relapsed/refractory multiple myeloma reimbursement context. · The fetched source is a company press release via PR Newswire, not a HIRA/NHIS final claims document or MFDS label. Exact reimbursed combination, prior-therapy criteria, and pricing rules require direct Korean payer verification. Confidence/conflicts: Medium-high for reimbursement signal; direct NHIS/HIRA final criteria not fetched. No conflict identified.
- selinexor (XPOVIO) with bortezomib and dexamethasone (XVd/SVd)[85]ApprovedXPO1 inhibitor plus proteasome inhibitor context; Adult multiple myeloma after one prior therapy/after at least one prior line. · Reimbursement is from a company press release and MFDS approval is from secondary medical-news reporting; direct MFDS label and NHIS/HIRA final reimbursement documents are still needed. The regimen name is reported as XPOVIO with bortezomib/dexamethasone and should not be treated as dosing guidance. Confidence/conflicts: Medium-high for Korea reimbursement/approval sequence, but direct MFDS and NHIS/HIRA criteria remain gaps. No conflict identified.
- teclistamab (Tecvayli)[78]ApprovedBCMA-targeted bispecific antibody context; prior PI, IMiD, and anti-CD38 exposure; Adult relapsed or refractory multiple myeloma after at least third-line or later therapy including PI, IMiD, and anti-CD38 monoclonal antibody. · The source is Korean-language HIRA committee output and needs human review. It records reimbursement-criteria setting at the cancer committee stage; final NHIS listing date, exact claims criteria, and MFDS label text remain separate checks. Confidence/conflicts: High for HIRA committee criteria-setting signal; final NHIS implementation and MFDS label remain gaps. No conflict identified. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
- tisagenlecleucel (Kymriah / 킴리아주)[86]ApprovedCD19-directed CAR-T context; Third-line or later adult relapsed/refractory DLBCL after two or more systemic therapy lines. · Korean-language payer source; human review needed. HIRA states CAR-T should be administered at suitable institutions by physicians experienced in anticancer therapy, reimbursement is recognized once per patient when administered, and use should follow MFDS-approved indication/label conditions. A separate HIRA case review stresses that eligibility timing is assessed at cell collection, not after drug infusion. Confidence/conflicts: High for HIRA reimbursement-criteria text; Korean-language source requires human review for downstream patient-facing wording. No conflict identified. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
Australia
- Australian supportive-care pathways for infection prophylaxis and VTE prophylaxis assessment[87]Standard option (per Myeloma Australia Medical and Scientific Advisory Group)not biomarker-specific; Australian supportive-care context for infection prevention and VTE prophylaxis/risk assessment during myeloma treatment. · eviQ explicitly notes definitive recommendations are limited and clinical discretion is required. Australian infection-prevention and VTE prophylaxis choices depend on regimen, transplant status, renal function, platelet count, infection history, vaccination status, and local funding. Confidence/conflicts: High for Australian supportive-care resource existence and scope; individualized prophylaxis remains clinician-dependent. No conflict identified.
- ciltacabtagene autoleucel (Carvykti)[88]TGA-registered (Australia)BCMA-targeted CAR T-cell therapy context; prior PI, IMiD, and anti-CD38 exposure; Adult relapsed or refractory multiple myeloma after at least three prior lines including PI, IMiD, and anti-CD38 antibody; MSAC re-application public-funding context focused on refractory/relapsed MM after more than three prior lines. · TGA registration does not by itself establish funded access. MSAC documents describe public-funding pathway issues for a highly specialised CAR-T therapy, including tertiary public hospital delivery and one successful infusion per lifetime in the public summary document. Local implementation and treatment-center capacity require separate confirmation. Confidence/conflicts: High for TGA registration and MSAC-supported outcome. The MSAC public summary document initially records deferred advice in November 2023 while the application page records final outcome supported; record both as a sequence rather than a conflict. Current NHRA implementation details remain a gap. Availability/reimbursement outside the approving regulator not established.
- daratumumab subcutaneous, bortezomib, and dexamethasone (DVd)[89]Standard option (per eviQ / Cancer Institute NSW)CD38-targeted monoclonal antibody plus proteasome inhibitor context; Relapsed/refractory multiple myeloma after at least one prior line of therapy. · eviQ is a clinical protocol source and does not itself establish PBS reimbursement or patient eligibility. The protocol highlights blood-transfusion interference from daratumumab and states a bone-modifying agent should be considered in symptomatic myeloma requiring treatment; denosumab is noted as TGA approved but not PBS reimbursed for the myeloma bone-disease indication. Confidence/conflicts: High for Australian protocol listing and setting; reimbursement/PBS status remains a separate gap. No conflict identified.
- dose-modified R-CODOX-M / R-IVAC with rituximab[90]Standard option (per eviQ / Cancer Institute NSW)risk-stratified Burkitt lymphoma; CNS disease status affects intrathecal treatment intensity; Risk-stratified frontline Burkitt lymphoma protocol overview. · eviQ is an Australian protocol resource, not a PBS reimbursement statement or a personalized recommendation. It emphasizes risk stratification, CNS involvement, toxicity, hospitalization/supportive care, and clinician judgment. Confidence/conflicts: Medium-high for Australia protocol guidance; product reimbursement details remain separate. No conflict identified.
- elranatamab (Elrexfio)[91]TGA-registered (Australia)BCMA-targeted bispecific antibody context; prior PI, IMiD, and anti-CD38 exposure with disease progression; Adult relapsed or refractory multiple myeloma after at least three prior therapies including PI, IMiD, anti-CD38 antibody, with progression on the last therapy. · TGA states the decision was based on overall response rate in a single-arm study, with continued approval dependent on verification and description of benefit in confirmatory trials. The AusPAR also says Elrexfio is included in the Black Triangle Scheme and describes CRS/ICANS risk-management concerns for BCMA/CD3 bispecifics. The Australian MSAG guideline reports elranatamab received a positive PBAC recommendation, but final PBS listing/access requires current PBS verification. Confidence/conflicts: High for TGA provisional approval and indication; medium for PBAC-positive status from guideline until direct PBAC/PBS page is fetched. No direct conflict identified. Availability/reimbursement outside the approving regulator not established.
- lenalidomide, bortezomib, and dexamethasone (RVd), including transplant-eligible and transplant-ineligible protocol variants[92]Standard option (per eviQ / Cancer Institute NSW)proteasome inhibitor plus IMiD context; Newly diagnosed multiple myeloma; protocol variants cover transplant-eligible, transplant-ineligible, and no-immediate-transplant-intent contexts. · eviQ states the protocol is based on evidence and reference-committee consensus and requires independent clinical judgment in individual circumstances. The page is a protocol overview, not a regulator label or PBS funding decision. Confidence/conflicts: High for Australian protocol-listing context; PBS/funding and exact product-label constraints remain gaps. No conflict identified.
- teclistamab (Tecvayli)[93]TGA-registered (Australia)BCMA-targeted bispecific antibody context; prior PI, IMiD, and anti-CD38 exposure; Adult relapsed or refractory multiple myeloma after at least three prior therapies including PI, IMiD, and anti-CD38 monoclonal antibody. · TGA states the provisional approval was based on overall response rate in a single-arm study, with continued approval dependent on verification and description of benefit in confirmatory trials. The Australian 2026 relapsed/refractory myeloma guideline states teclistamab is TGA approved but not yet PBS reimbursed as of the guideline's January 2026 content, so public funding requires current local confirmation. Confidence/conflicts: High for TGA provisional approval; medium-high for PBS non-reimbursement note from MSAG guideline as of January 2026. Current PBS status should be refreshed before surfacing as live access.
China
- DA-EPOCH-R; CODOX-M-R; CODOX-M/IVAC-R; Hyper-CVAD/MA-R[94]Standard option (per China Anti-Cancer Association Lymphoma Committee / Holistic Integrative Oncology)CD20-directed treatment context through rituximab-containing regimens; Newly diagnosed Burkitt lymphoma, frontline treatment with CNS prophylaxis. · This China-focused guideline is not an NMPA label or NRDL payer record. It supports guideline-level treatment options to discuss with a hematology/oncology team; actual regimen choice, availability, inpatient capacity, and reimbursement require local confirmation. Confidence/conflicts: Medium-high for China guideline-supported regimen list; NMPA label and reimbursement details remain gaps. No conflict identified.
- brentuximab vedotin (Adcetris)[64]ApprovedCD30-positive Hodgkin lymphoma; Adult relapsed or refractory CD30-positive Hodgkin lymphoma in China. · This is a company announcement, not the direct NMPA label or reimbursement listing. Current Chinese label, provincial reimbursement, and hospital procurement must be verified locally. Confidence/conflicts: Medium-high for China approval signal; direct NMPA label/reimbursement remains a gap. No conflict identified.
- ciltacabtagene autoleucel injection (Carvykti / Kaweidi)[95]NMPA-approved (China)BCMA-targeted CAR T-cell therapy context; Adult relapsed/refractory myeloma after three or more prior lines including PI and IMiD. · The NMPA page verifies conditional approval but does not establish NRDL reimbursement, hospital qualification, manufacturing timeline, or individual eligibility. Confidence/conflicts: High for China conditional approval signal; direct label/NRDL gap remains. No conflict identified.
- clinical trial participation; R-ICE; R-GDP; EPOCH-R; IVAC-R; ASCT or allo-SCT consolidation for suitable responders; best supportive care including palliative involved-site radiation therapy[94]Standard option (per China Anti-Cancer Association Lymphoma Committee / Holistic Integrative Oncology)CD20-directed salvage context when rituximab is used; Relapsed or refractory Burkitt lymphoma. · The guideline does not establish open trial slots, transplant eligibility, drug reimbursement, or radiation access for a specific hospital. It frames options by disease setting and suitability; local multidisciplinary review remains necessary. Confidence/conflicts: Medium-high for China guideline-supported relapsed/refractory option categories; trial availability, NMPA labels, transplant-center access, and reimbursement remain gaps. No conflict identified.
- glofitamab (Columvi / 高罗华)[96]NMPA: conditionally approvedCD20-positive B-cell target and CD3 T-cell engager mechanism; source indication is DLBCL after prior systemic therapy; Adult relapsed/refractory DLBCL after two or more systemic therapy lines. · The NMPA news item verifies conditional marketing approval and indication summary but not reimbursement, hospital procurement, or full label risk-management requirements. Confidence/conflicts: High for China NMPA conditional approval and indication summary; reimbursement/procurement remains a gap. No conflict identified.
- pirtobrutinib (Jaypirca)[97]ApprovedBTK inhibitor prior-treatment context; Adult R/R MCL after at least two prior systemic therapies including a BTK inhibitor. · Company press-release signal; direct NMPA approval notice, product label, National Reimbursement Drug List status, provincial procurement, and hospital formulary access remain gaps. Do not infer routine reimbursed availability from the approval signal alone. Confidence/conflicts: Medium for China MCL approval signal; direct NMPA label not fetched in this cycle. No conflict identified.
- rocbrutinib (LP-168)[98]NMPA: conditionally approvedBTK inhibitor prior-treatment context; resistance-mutation context described by developer; Adult R/R MCL after at least two prior systemic therapies including BTK inhibitors. · Company press-release signal with secondary oncology-news corroboration; direct NMPA label, product trade name, NRDL/procurement status, and hospital access remain gaps. The source states approval was based primarily on a nationwide, multicenter, open-label, single-arm phase 2 ROCK-1 study and that additional phase 3 confirmation is part of ongoing development; this should be surfaced as an option to discuss, not as a comparative claim. Confidence/conflicts: Medium for accelerated approval signal; direct NMPA label not fetched in this cycle. No conflict identified.
- selinexor (XPOVIO / Xpovio)[99]ApprovedXPO1 inhibitor context; PI/IMiD/anti-CD38 refractory context; Adult relapsed/refractory multiple myeloma refractory to at least one PI, one IMiD, and one anti-CD38 monoclonal antibody. · The source is Chinese-language NHSA public application material and needs human review. It verifies NRDL/payment-scope text for the stated MM indication but not provincial implementation, hospital prescribing rules, or later updates after the listed agreement expiry. Confidence/conflicts: High for NHSA payment-scope text as fetched; current post-2025 renewal status remains a gap. No conflict identified. Primary source is in Chinese. English summary pending human review — confirm exact wording with your care team. Availability/reimbursement outside the approving regulator not established.
- selinexor (XPOVIO / Xpovio) with bortezomib and dexamethasone (XVd)[100]NMPA-approved (China)XPO1 inhibitor plus proteasome inhibitor context; Adult multiple myeloma after at least one prior line of therapy. · The fetched source is a Chinese-language company announcement and needs human review before patient-facing reuse. It reports NMPA approval but is not a direct NMPA label. Current reimbursement scope for the new XVd indication was not verified in this pass. Confidence/conflicts: Medium-high for NMPA approval signal; direct NMPA label and reimbursement details remain gaps. No conflict identified. Primary source is in Chinese. English summary pending human review — confirm exact wording with your care team.
- selinexor (XPOVIO / Xpovio) with dexamethasone[101]NMPA-approved (China)XPO1 inhibitor context; prior PI, IMiD, and anti-CD38 refractory context; Adult relapsed or refractory multiple myeloma after prior PI, IMiD, and anti-CD38 exposure. · This is a company/PR Newswire report of an NMPA approval, not a directly fetched NMPA label. The source describes conditional approval and a confirmatory trial. Current label wording and provincial access require direct regulator or label verification. Confidence/conflicts: Medium-high for approval signal; direct NMPA label not fetched. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- tazemetostat (Tazverik)[102]Withdrawn / recalled in China (Mar 2026)EZH2 mutation-positive; Adult R/R EZH2-mutated FL after two or more prior systemic therapies in the approval signal; not a current routine option based on the fetched withdrawal/recall update. · This is a record of an approval-to-withdrawal sequence. It should not be surfaced as a currently available China option without a new NMPA/local availability check. Direct NMPA label/recall notices remain gaps. Confidence/conflicts: Medium-high for approval and withdrawal signals; direct NMPA documents unavailable in this cycle. Conflict/sequence explicitly noted: conditional approval in 2025 followed by withdrawal/recall action in 2026. Tazverik (tazemetostat) was withdrawn and recalled in the Chinese mainland, Hong Kong, and Macau on 9 March 2026 after the global SYMPHONY-1 safety signal of secondary hematologic malignancies (incl. fatal MDS/acute leukemia). HUTCHMED suspended all sales/shipments and instructed institutions to stop prescribing and pharmacies to stop dispensing; NHSA removed it from the commercial-insurance innovative drug directory. The prior 2025 NMPA conditional approval is superseded — this is NOT a currently available option in China.
- teclistamab (Tecvayli)[103]NMPA-approved (China)BCMA/CD3 bispecific antibody context; Adult relapsed or refractory multiple myeloma after at least three prior lines of treatment. · This is a secondary medical-news report summarizing a J&J Chinese-language release, not a directly fetched NMPA label. Reimbursement, hospital access, and exact prior-therapy wording require direct NMPA/label or payer confirmation before patient-facing use. Confidence/conflicts: Medium for China approval signal due to secondary source; direct NMPA label and reimbursement status remain gaps. No conflict identified.
Russia
- ABVD chemotherapy plus radiation therapy to initially involved zones[104]Standard option (per MedElement clinical recommendations portal / Russian Hodgkin lymphoma clinical recommendations mirror)PET/CT-confirmed staging; no molecular biomarker restriction.; First-line treatment for PET/CT-confirmed early-stage favorable classical Hodgkin lymphoma in adults aged 18-60. · Guideline support does not establish suitability for a specific patient, radiation-center access, fertility preservation counseling, or comorbidity-specific modifications. Confidence/conflicts: Medium-high for Russian guideline framework; source is Russian-language and requires human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Biopsy/PET-CT transformation workup; obinutuzumab plus bendamustine after rituximab-refractory/early relapse; rituximab or obinutuzumab plus alternative chemotherapy after later relapse; rituximab plus lenalidomide; aggressive-NHL relapse regimens such as GEMOX, ICE, DHAP, ESHAP, GDP with monoclonal antibodies in selected transplant-candidate refractory cases; autologous or allogeneic transplant contexts; mosunetuzumab fixed-duration monotherapy in adult regimen appendix[105]Standard option (per MedElement clinical recommendations portal / Russian follicular lymphoma clinical recommendations mirror)Suspected transformation to DLBCL by clinical features/PET activity; POD24 and rituximab-refractory timing in source.; Relapsed/refractory follicular lymphoma, suspected transformation, early relapse/POD24, transplant-candidate refractory disease, and adult later-line bispecific-antibody context. · Guideline support does not prove product registration, procurement, funding, CAR-T/bispecific availability, or transplant eligibility. Source is Russian-language and needs human review before patient-facing reuse. Confidence/conflicts: Medium for Russian guideline relapse/transformation framework; access and regulatory status for named agents remain unverified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Bortezomib-lenalidomide-dexamethasone (VRd/RVD), bortezomib-cyclophosphamide-dexamethasone (VCd), bortezomib-doxorubicin-dexamethasone (PAd), autologous HSCT, consolidation, bortezomib or lenalidomide maintenance[106]Standard option (per MedElement clinical recommendations portal / Russian multiple myeloma clinical recommendations mirror)del(17p) mentioned in maintenance commentary; MRD monitoring after auto-HSCT in source.; Newly diagnosed transplant-eligible adult MM; post-induction autologous HSCT; post-transplant consolidation/maintenance. · Russian-language guideline mirror; human review is needed. Guideline support does not establish drug procurement, transplant-center acceptance, or individual fitness. Confidence/conflicts: Medium-high for Russian guideline framework; access/procurement remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Brentuximab vedotin plus AVD chemotherapy (BV-AVD); primary G-CSF prophylaxis[104]Standard option (per MedElement clinical recommendations portal / Russian Hodgkin lymphoma clinical recommendations mirror)No biomarker restriction stated in fetched source for this regimen context.; Selected first-line advanced classical Hodgkin lymphoma contexts, including stage IV disease and high bleomycin pneumonitis risk. · This is guideline support, not a direct Russian regulator label, procurement, or reimbursement confirmation for brentuximab vedotin. G-CSF support is part of the source-described regimen context, not a standalone eligibility claim. Confidence/conflicts: Medium for guideline-stated selected-context use; direct product registration/procurement remains unverified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- CAR-T cell therapy; local radiation therapy as consolidation/therapeutic or preparation-to-CAR-T context[107]Standard option (per MedElement mirror of Russian Federation clinical recommendations)CD19-directed CAR-T context; radiation context independent of biomarker; Adult relapsed/refractory aggressive B-cell lymphoma including DLBCL after two lines, or TP53-mutated first-line refractory disease; relapse radiation consolidation, therapeutic, CAR-T-bridging/preparation, or urgent-symptom scenarios. · Russian-language guideline mirror; human review needed. The source does not identify specific CAR-T products registered/procured in Russia, treatment-center capacity, manufacturing access, or payer coverage. Confidence/conflicts: Medium-high for guideline recommendation; direct CAR-T product availability and reimbursement remain unresolved. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- CNS prophylaxis with intrathecal chemotherapy; high-dose methotrexate elimination monitoring with calcium folinate adjustment; central venous catheter and supportive-care measures; explicit non-use of R-CHOP as Burkitt therapy in source[107]Standard option (per MedElement clinical recommendations portal / Russian aggressive non-follicular B-cell lymphoma clinical recommendations mirror)CNS involvement/risk context; high-dose methotrexate and intrathecal CNS prophylaxis in source.; Adult Burkitt lymphoma supportive/CNS-prophylaxis framework during first-line intensive treatment. · This is a protocol-supportive framework, not dosing advice for patients. Intrathecal therapy, methotrexate monitoring and central-line care require specialist inpatient management. Confidence/conflicts: Medium-high for Russian guideline supportive/CNS framework; local implementation remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Emergency stabilization; high-intensity pulse chemotherapy with or without rituximab; LB-M-22 (R-mNHL-BFM-90/R-EPOCH), LB-M-04 plus or minus rituximab, R-Hyper-CVAD/R-HMA, LMB 95, CODOX-M/IVAC plus or minus rituximab, R-DA-EPOCH for selected older/non-intensive candidates without CNS involvement[107]Standard option (per MedElement clinical recommendations portal / Russian aggressive non-follicular B-cell lymphoma clinical recommendations mirror)c-MYC rearrangement described in source definition; CNS, marrow, LDH and bulky/extranodal factors described as risk/intensification factors.; Adult first-line Burkitt lymphoma, including urgent presentation and selected older/non-intensive candidates. · Guideline support does not establish regimen availability, ICU/supportive-care capacity, product procurement, or individual fitness for intensive therapy. Source is Russian-language and needs human review. Confidence/conflicts: Medium-high for Russian guideline adult framework; direct drug/protocol access remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Modern targeted regimens where available; VBMCP (M2), DCEP, cyclophosphamide with prednisone or dexamethasone for selected frail/palliative relapse, high-dose dexamethasone for cytopenia context, palliative radiation for uncontrolled pain, pathological-fracture threat or spinal cord compression[106]Standard option (per MedElement clinical recommendations portal / Russian multiple myeloma clinical recommendations mirror)Not biomarker-restricted in fetched source excerpt; cytopenia, frailty/age and pain/fracture/spinal-cord-compression contexts described.; Relapsed MM, frail/older or poor-condition palliative contexts, cytopenia context, and myeloma bone/pain/cord-compression complications. · These are source-described fallback/supportive/palliative contexts, not preferred rankings or individualized recommendations. Local radiation access, pain management and urgent spine/fracture pathways must be confirmed clinically. Confidence/conflicts: Medium for Russian guideline relapse/supportive framework; product-specific access remains unverified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Multi-component BFM-based polychemotherapy with rituximab[107]Standard option (per MedElement clinical recommendations portal / Russian aggressive non-follicular B-cell lymphoma clinical recommendations mirror)Mature B-cell aggressive lymphoma category; CD20-directed rituximab included.; First-line pediatric/adolescent aggressive non-follicular B-cell lymphoma including Burkitt lymphoma. · Russian-language guideline mirror; human review is needed. The source supports a pediatric protocol framework, not access at every Russian center. Confidence/conflicts: Medium-high for guideline pediatric framework; direct pediatric center pathway/procurement remains a gap. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- PET-CT staging/response assessment, CT, biopsy-directed morphology and immunohistochemistry[104]Standard option (per MedElement mirror of Russian Federation clinical recommendations)Histologic and immunohistochemical confirmation required; CD30 status relevant for brentuximab contexts; Initial staging, response assessment after treatment, suspected relapse, and radiation planning. · Russian-language source requires human review. PET-CT availability and reimbursement may vary by Russian region and center. Confidence/conflicts: Medium-high for Russia guideline pathway; local implementation varies. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- PET-adapted treatment planning with interim PET/CT after 2 cycles of chemotherapy[104]Standard option (per MedElement clinical recommendations portal / Russian Hodgkin lymphoma clinical recommendations mirror)PET/CT response status; no molecular biomarker restriction.; Response assessment and treatment-program adjustment during first-line chemotherapy-based treatment. · Russian-language guideline mirror; human review is needed before patient-facing reuse. The source supports a planning/assessment pathway but does not establish scanner access at every center. Confidence/conflicts: Medium-high for guideline-supported PET-adapted planning; direct official PDF and local access details remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- R-CHOP, R-CHOEP, R-DA-EPOCH, R-miniCHOP/R-CVP/R-CEOP/R-GCVP/R-CCOP/R-CNOP/R-MACOP-B options; radiation therapy in selected stage I-II post-treatment contexts; Pola-R-CHP discussion for newly diagnosed DLBCL with IPI 2-5 in source commentary[107]Established standard of carePET/CT Deauville response assessment; high-grade B-cell lymphoma/DHL/DEL contexts discussed separately in source.; First-line treatment and post-treatment consolidation planning for newly diagnosed adult DLBCL. · Russian-language guideline mirror; human review is needed. The Pola-R-CHP statement is recorded as guideline commentary/evidence context and does not establish Russian label, procurement, or reimbursement. Confidence/conflicts: Medium-high for Russian guideline framework; direct official PDF and product access details remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- R-DHAP, R-ESHAP, R-ICE, R-GDP, R-GemOx, R-DHAX, R-MINE, polatuzumab vedotin plus R-ICE or BR, glofitamab monotherapy or glofitamab-GemOx, high-dose chemotherapy with autologous hematopoietic cell transplant, CAR-T cell therapy[107]Standard option (per MedElement clinical recommendations portal / Russian aggressive non-follicular B-cell lymphoma clinical recommendations mirror)TP53 mutation context for CAR-T consideration after first-line refractory disease; non-GCB context for selected rituximab/ibrutinib/lenalidomide option in source; no universal mutation restriction.; Relapsed/refractory DLBCL and aggressive B-cell lymphoma; salvage-to-autologous transplant, transplant-ineligible later lines, and selected CAR-T contexts. · Guideline support does not establish Russian product registration, center capability, procurement, reimbursement, or individual transplant/CAR-T eligibility. Some options are broader aggressive B-cell lymphoma contexts rather than DLBCL-only. Confidence/conflicts: Medium for Russian guideline salvage/CAR-T framework; direct regulator and center-access verification remains needed. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- R-DHAP, R-ESHAP, R-ICE, R-GDP, R-GemOx, R-DHAX, R-MINE; polatuzumab vedotin plus R-ICE or plus bendamustine-rituximab; glofitamab monotherapy or glofitamab-GemOx in DLBCL contexts[107]Standard option (per MedElement mirror of Russian Federation clinical recommendations)CD20 context for rituximab-containing salvage; CD79b context for polatuzumab; CD20xCD3 bispecific context for glofitamab; Relapsed/refractory adult DLBCL and related aggressive B-cell lymphomas; intensive salvage with possible autologous stem-cell transplant consolidation for responders, or less-intensive regimens for older/comorbid/non-auto-HSCT candidates. · Russian-language guideline mirror; human review needed. The source includes guideline pathways but does not verify registration/procurement for every named medicine in Russia. Some regimens contain off-label-marked components; exact local label and payer status must be checked. Confidence/conflicts: Medium-high for guideline pathway; local registration/procurement unresolved. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- R-HyperCVAD/R-HMA, platinum-containing regimens such as R-DHAP/R-GemOx/R-GIDIOX, R-BAC, acalabrutinib, zanubrutinib, ibrutinib alone or with rituximab, venetoclax, BTK inhibitor plus venetoclax with rituximab or obinutuzumab, lenalidomide-rituximab, ibrutinib-lenalidomide-rituximab, allogeneic HSCT, CAR-T cell therapy, autologous HSCT if not done earlier and response achieved, bortezomib-containing options, radiation for local relapse, clinical trials[108]Standard option (per MedElement clinical recommendations portal / Russian mantle cell lymphoma clinical recommendations mirror)TP53 and aggressive-relapse context referenced in guideline; prior BTK inhibitor exposure relevant.; Relapsed or progressive MCL, including aggressive relapse, post-BTK contexts and local relapse. · Guideline-listed options do not confirm Russian product registration, procurement, reimbursement, center capability, trial availability, or individual eligibility. Source is Russian-language and requires human review. Confidence/conflicts: Medium for Russian guideline relapse framework; direct labels/procurement and CAR-T access remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Radiation therapy; rituximab monotherapy; anti-CD20 chemoimmunotherapy with rituximab or obinutuzumab plus CHOP, bendamustine, or CVP; chlorambucil plus rituximab in selected older/comorbid patients[105]Standard option (per MedElement clinical recommendations portal / Russian follicular lymphoma clinical recommendations mirror)Cytologic grade 1-2 or grade 3 in source; CD20-directed therapy context.; First-line adult follicular lymphoma, by stage, grade, tumor burden and fitness context. · Russian-language guideline mirror; human review is needed. Guideline support does not establish direct product registration, procurement, reimbursement, or radiation-center access. Confidence/conflicts: Medium-high for guideline framework; direct official/procurement checks remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Salvage chemotherapy regimens including ICE, DHAP, IGEV, BeGEV, GDP, ESHAP, GemOx, IEP; brentuximab vedotin; PD-1 inhibitors nivolumab and pembrolizumab; high-dose chemotherapy with autologous HSCT; allogeneic HSCT consultation in selected post-autoHSCT contexts[104]Standard option (per MedElement clinical recommendations portal / Russian Hodgkin lymphoma clinical recommendations mirror)PET/CT response and remission status; no molecular biomarker restriction in fetched source.; Second-line relapsed/refractory therapy, bridge to high-dose chemotherapy with autologous HSCT, and selected post-autoHSCT relapse contexts. · Guideline discussion does not prove access, funding, center capability, or registration status for each named drug or transplant procedure. Allogeneic HSCT is recorded as a consultation/decision pathway, not routine eligibility. Confidence/conflicts: Medium for Russian guideline framework; product labels, procurement and transplant-center criteria remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- Watch-and-wait for selected indolent stage I-II; R-CHOP plus local radiation for selected stage I-II; intensive induction such as R-BAC/R-HD-Ara-C, R-CHOP/R-DHAP, R-MaxiCHOP/R-HD-AraC, R-HyperCVAD/R-HD-Met-AraC; autologous HSCT consolidation; rituximab maintenance; BTK inhibitor maintenance or BTK inhibitor plus venetoclax and anti-CD20 antibody in TP53-mutated contexts[108]Standard option (per MedElement clinical recommendations portal / Russian mantle cell lymphoma clinical recommendations mirror)TP53 mutation context in source; CCND1 translocation is common diagnostic feature described by guideline.; First-line adult MCL by stage, age/fitness, transplant candidacy and TP53 context. · Russian-language guideline mirror; human review is needed. Guideline support does not establish access, procurement, reimbursement, or transplant/CAR-T center availability. Confidence/conflicts: Medium for Russian guideline framework; direct regulator/procurement checks remain gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- bortezomib-based induction regimens including PAD and VCD; autologous hematopoietic stem-cell transplantation pathway[109]Standard option (per blood.ru / Russian hematology guideline document host)not biomarker-specific; proteasome inhibitor and chemo-immunotherapy induction context; Initial therapy for newly diagnosed patients considered candidates for autologous stem-cell transplantation. · The source is a Russian-language clinical guideline mirror/PDF, not a product registration or procurement database. Regimen details require Russian-language clinical review before patient-facing reuse; local center experience and transplant eligibility are not inferred. Confidence/conflicts: Medium-high for guideline pathway; Russian-language source requires human review and direct Ministry/Garant source refresh. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- brentuximab vedotin (Adcetris)[104]Standard option (per MedElement mirror of Russian Federation clinical recommendations)CD30-positive cHL for brentuximab vedotin; Post-auto-HSCT consolidation in increased-risk cHL; relapsed/refractory cHL after auto-HSCT or when auto-HSCT/multi-agent chemotherapy is not feasible. · This does not confirm current Russian drug label, procurement, or reimbursement. Guideline notes monitoring during consolidation; individual duration and dosing are not cataloged here. Confidence/conflicts: Medium-high for Russia guideline recommendation; direct product/procurement gap remains. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- cyclophosphamide with prednisone or dexamethasone; high-dose dexamethasone monotherapy[106]Standard option (per MedElement mirror of Russian Federation 2024 clinical recommendations)not biomarker-specific; Relapsed MM with advanced age/poor physical condition; cytopenia-limited MM context. · The source is Russian-language and should be human-reviewed. The entry is not a recommendation for any individual patient and does not establish safety, eligibility, or superiority. Confidence/conflicts: Medium for palliative/supportive guideline content; language and direct official-source verification remain gaps. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- daratumumab plus bortezomib, melphalan, and prednisone (Dara-VMP); bortezomib/dexamethasone (VD); bortezomib/cyclophosphamide/prednisone (VCP); lenalidomide/dexamethasone (Rd)[109]Standard option (per blood.ru / Russian hematology guideline document host)CD38-targeted monoclonal antibody and proteasome-inhibitor context; Initial therapy for newly diagnosed multiple myeloma in patients not proceeding to transplant or with age/fitness considerations as described in the guideline. · The guideline text is Russian-language and not a GRLS registration/procurement source. The regimen-table content includes dosing detail that should not be surfaced without clinical and human-language review; payer and hospital formulary status remain separate. Confidence/conflicts: Medium for guideline-listed Russian options; exact availability, registration, and reimbursement not verified. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- nivolumab (Opdivo), pembrolizumab (Keytruda), allogeneic hematopoietic stem cell transplantation consultation[104]Standard option (per MedElement mirror of Russian Federation clinical recommendations)PD-1 checkpoint inhibitor context; Adult R/R cHL after auto-HSCT/brentuximab or multiple systemic lines; pediatric R/R cHL age 3+ in specified contexts; post-response allogeneic transplant consultation. · Russian-language source requires human review. Direct drug labels, GRLS cards, regional procurement, pediatric center access, and allogeneic transplant eligibility are not verified. Confidence/conflicts: Medium-high for guideline recommendation; direct label/procurement and transplant-center access remain gaps. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- relapse regimens including bortezomib-based, lenalidomide/dexamethasone (Rd/RD), VRD, RAD, RCD/RCP, bendamustine-based, pomalidomide/dexamethasone, and daratumumab combinations (Dara-Rd, Dara-VD)[106]Standard option (per MedElement mirror of Russian Federation 2024 clinical recommendations)not biomarker-specific; prior-therapy-sensitive versus refractory context; Relapsed multiple myeloma; regimen choice depends on prior response/refractoriness and clinical features per guideline. · This is a Russian-language guideline pathway, not a proof of every regimen's Russian registration or reimbursement. The source should be human-reviewed before patient-facing display, especially around exact regimen names and starred/off-label notation. Confidence/conflicts: Medium-high for guideline relapse framework; lower for direct availability because GRLS/procurement not fetched. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP); polatuzumab vedotin with rituximab, cyclophosphamide, doxorubicin, and prednisone/prednisolone (Pola-R-CHP) as an alternative for selected intermediate/high-risk newly diagnosed DLBCL[107]Standard option (per MedElement mirror of Russian Federation clinical recommendations)CD20-positive B-cell lymphoma context; guideline also discusses DEL/DHL/high-risk subgroups separately; First-line adult newly diagnosed DLBCL; Pola-R-CHP alternative in intermediate/high-risk IPI 2-5 DLBCL. · Russian-language guideline mirror; human review needed. Guideline-recommended status does not prove product registration, procurement, or regional reimbursement. Some listed drugs are marked in the guideline with special/off-label symbols in specific regimens; local label and formulary should be checked. Confidence/conflicts: Medium-high for guideline content; Russian-language human review and direct Ministry/GRLS source checks remain gaps. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
- salvage chemotherapy regimens such as ICE, DHAP, IGEV, BeGEV, GDP, ESHAP, GemOx, IEP; brentuximab vedotin and PD-1 inhibitor-containing second-line approaches[104]Standard option (per MedElement mirror of Russian Federation clinical recommendations)CD30-positive context for brentuximab; PET-negative remission status before auto-HSCT matters in guideline pathway; Second-line therapy for relapsed/refractory cHL, especially when aiming for PET-negative remission before high-dose chemotherapy and autologous HSCT. · Guideline recommendation does not verify drug stock, GRLS label, regional procurement, or transplant-center capacity. Russian-language source requires human review. Confidence/conflicts: Medium-high for guideline sequencing; access/procurement confidence remains low. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Thailand
- Bendamustine hydrochloride (Ribomustin) monotherapy or with rituximab[110]ApprovedCD20-positive in previously untreated indolent stage III-IV NHL combination-with-rituximab setting.; Relapsed/refractory indolent NHL; previously untreated indolent CD20-positive stage III-IV NHL with rituximab. · The label is indolent NHL rather than follicular lymphoma-only; local subtype confirmation, payer rules, and regimen selection are not inferred. Confidence/conflicts: Medium-high; source supports indolent NHL indications, with follicular lymphoma-specific mapping requiring clinician subtype confirmation. Availability/reimbursement outside the approving regulator not established.
- Bortezomib (Velcade) for MCL; bortezomib (Bortoma) with rituximab, cyclophosphamide, doxorubicin and prednisone[111]EMA authorisedNot biomarker-restricted in fetched bortezomib label text.; Relapsed MCL for Velcade section; previously untreated adult MCL unsuitable for hematopoietic stem cell transplantation for Bortoma combination label. · Two Thai regulator-hosted product-information sources support related bortezomib MCL contexts. They do not establish which bortezomib product is stocked, reimbursed, or clinically preferred. Confidence/conflicts: High for product-information indication text; exact reimbursement and product substitution remain gaps.
- Daratumumab (Darzalex) combinations and monotherapy[112]ApprovedNot biomarker-restricted in fetched label text.; Newly diagnosed transplant-eligible and transplant-ineligible adult MM; relapsed/refractory adult MM across source-stated prior-therapy contexts. · Product information does not establish Thai reimbursement, subcutaneous-versus-intravenous product substitution, or individual regimen choice. Confidence/conflicts: High for Thai label indication text; payer/access sequencing remains a gap.
- Ixazomib (Ninlaro) with lenalidomide and dexamethasone; ixazomib maintenance after autologous stem-cell transplantation or without stem-cell transplantation[113]ApprovedNot biomarker-restricted in fetched label text.; Adult MM after at least one prior therapy; adult MM maintenance after autologous SCT or non-SCT treatment. · Product information does not establish reimbursement, drug-combination availability, or suitability for a specific patient. Confidence/conflicts: High for Thai label indication text; payer and sequencing remain gaps.
- Lenalidomide[114]ApprovedNot biomarker-restricted in fetched label text.; Adult relapsed or refractory MCL. · Product information does not establish payer coverage, local availability, pregnancy-prevention controls, or sequencing relative to BTK inhibitors or cellular therapy. Confidence/conflicts: High for Thai label indication text; local controlled-distribution and payer details remain gaps. Availability/reimbursement outside the approving regulator not established.
- Lenalidomide with dexamethasone, bortezomib-dexamethasone, or melphalan-prednisone; lenalidomide maintenance after autologous stem-cell transplantation[115]ApprovedNot biomarker-restricted in fetched label text.; Post-autologous-SCT maintenance; previously untreated transplant-ineligible adult MM; adult MM after at least one prior therapy. · Product information does not establish reimbursement, pregnancy-prevention program logistics, or regimen suitability for an individual patient. Confidence/conflicts: High for Thai label indication text; payer and controlled-distribution details remain gaps.
- Lenalidomide with rituximab; zanubrutinib (Brukinsa) with obinutuzumab[115]ApprovedGrade 1-3A for lenalidomide-rituximab label; no mutation biomarker. Obinutuzumab partner implied for zanubrutinib label.; Previously treated adult follicular lymphoma grade 1-3A for lenalidomide-rituximab; adult follicular lymphoma after at least 2 prior therapies for zanubrutinib-obinutuzumab. · Two separate Thai product-information sources support different relapsed/previously treated settings. They do not establish payer coverage, obinutuzumab availability, sequencing, or suitability for an individual patient. Confidence/conflicts: High for Thai label indication text; sequencing and payer coverage remain gaps. Availability/reimbursement outside the approving regulator not established.
- Pembrolizumab (Keytruda)[116]ApprovedNot biomarker-restricted in fetched label text.; Relapsed or refractory classical Hodgkin lymphoma in adults and pediatric patients. · The prescribing information supports the Thai label indication but does not establish reimbursement, stock availability, local pathway placement, or suitability for any individual patient. Confidence/conflicts: High for Thai product-information indication text; no reimbursement or comparative-effectiveness claim made.
- Polatuzumab vedotin (Polivy) with bendamustine and rituximab[117]EMA authorisedNot biomarker-restricted in fetched Polivy indication text.; Adult relapsed/refractory DLBCL, transplant-ineligible. · Product information does not establish reimbursement, local procurement, transplant-center decision-making, or individual eligibility. Confidence/conflicts: High for Thai product-information indication text; first-line polatuzumab status in Thailand remains a gap.
- Rituximab (Ruxience) with CHOP chemotherapy; pediatric systemic chemotherapy contexts for CD20-positive DLBCL/BL/BAL/BLL[118]ApprovedCD20-positive context for pediatric non-Hodgkin lymphoma; adult DLBCL indication text does not state a mutation biomarker.; Adult diffuse large B-cell non-Hodgkin lymphoma with CHOP; pediatric previously untreated advanced-stage CD20-positive DLBCL/BL/BAL/BLL. · Product information does not establish payer coverage, hospital formulary status, or whether a specific patient should receive rituximab. The pediatric text includes broader mature B-cell lymphoma entities beyond DLBCL. Confidence/conflicts: High for Thai product-information indication text; payer and exact protocol access remain gaps. Availability/reimbursement outside the approving regulator not established.
- Rituximab (Ruxience) with chemotherapy, maintenance therapy, or monotherapy in relapsed/refractory settings[118]ApprovedCD20-positive biology implied by anti-CD20 rituximab use; no mutation biomarker stated in fetched label section.; Previously untreated or relapsed/refractory follicular lymphoma induction; maintenance after response; adult relapsed/refractory monotherapy contexts. · Product information does not establish payer coverage, hospital formulary access, CD20 testing workflow, or individual suitability. Confidence/conflicts: High for Thai product-information follicular lymphoma indication text; no payer claim made. Availability/reimbursement outside the approving regulator not established.
- Rituximab controlled-use pathway with chemotherapy according to ThaiPOG Mature B-cell lymphoma protocol[119]ApprovedMature B-cell lymphoma pathway; CD20-directed rituximab context.; Pediatric mature B-cell lymphoma controlled-use access context; Burkitt lymphoma is a mature B-cell lymphoma category but the fetched excerpt is protocol-level rather than Burkitt-only. · Thai-language access criteria require human review before patient-facing reuse. This is not a broad Thai approval claim for every Burkitt setting and does not mean any individual qualifies. Confidence/conflicts: Medium for Burkitt-relevant mature B-cell lymphoma access pathway; exact current Thai payer operations require human review. 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.
- Rituximab controlled-use/reimbursement pathway[119]ApprovedCD20-positive by immunohistochemistry in pediatric criteria; adult criteria are DLBCL-focused in the fetched Thai controlled-use document.; Controlled-use access criteria for rituximab in adult DLBCL and pediatric DLBCL. · Thai-language administrative/clinical criteria need human review before patient-facing reuse. The criteria describe an access-control pathway and do not mean any individual qualifies or that every payer/hospital uses the same process. Confidence/conflicts: Medium-high for the existence of Thai controlled-use criteria; translation/human review needed for detailed criteria and current payer operations. 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.
- Zanubrutinib (Brukinsa)[120]ApprovedNo mutation biomarker restriction stated in fetched label text.; Adult MCL after at least one prior therapy. · Product information does not establish reimbursement, local formulary access, sequencing versus other BTK inhibitors, or suitability for a specific patient. Confidence/conflicts: High for Thai label indication text; payer and sequencing remain gaps.
- bortezomib (Velcade)[111]FDA-approvedproteasome inhibitor context; Broad multiple myeloma label contexts including untreated transplant-ineligible, transplant-eligible induction, relapsed, and retreatment sections. · The source verifies Thailand-hosted product information but does not establish payer coverage, hospital formulary, or patient-specific suitability. It includes neuropathy, thrombocytopenia, neutropenia, and other toxicity warnings that require clinician monitoring. Confidence/conflicts: High for Thailand label indication; payer/access gap remains. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- brentuximab vedotin (Adcetris)[121]FDA-approvedCD30-positive Hodgkin lymphoma; Previously untreated adult CD30+ stage III/IV HL with AVD; post-ASCT consolidation in increased-risk adults; relapsed/refractory adult CD30+ HL after ASCT or after at least two prior therapies when ASCT/multi-agent chemotherapy is not an option. · Thai payer, hospital formulary, and infusion-center access were not verified. The NDI-hosted product information should be checked against the current Thai registration detail and treating hospital policy. Confidence/conflicts: High for Thai NDI-hosted indication text; payer/access confidence remains low. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- daratumumab and hyaluronidase (Darzalex SC)[122]FDA-approvedCD38-targeted monoclonal antibody context; Adult multiple myeloma; newly diagnosed transplant-eligible and additional combination contexts described in the local product information. · The fetched Thailand product information supports local labeling, not payer coverage. The same document states pediatric safety/effectiveness are not established and includes systemic administration-reaction and infection/cytopenia safety details. Confidence/conflicts: High for Thailand label indication; payer/access gap remains. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- ibrutinib (Imbruvica)[123]FDA-approvedBTK inhibitor therapy context; Adult MCL after at least one prior therapy. · The fetched Thai NDI-hosted product information supports the label indication but does not establish National List of Essential Medicines status, reimbursement, procurement, hospital formulary access, or patient-specific eligibility. The document carries accelerated-approval language based on overall response rate. Confidence/conflicts: High for Thailand label indication; payer/access gap remains. No conflict identified.
- pembrolizumab (Keytruda)[124]FDA-approvedPD-1 checkpoint inhibitor context; no biomarker restriction stated in fetched Thai label excerpt; Adult and pediatric relapsed/refractory classical Hodgkin lymphoma. · Thai payer and hospital formulary status were not verified. The Thai-language label text requires human review for legal wording; do not infer individual eligibility or sequencing versus brentuximab, transplant, or chemotherapy. Confidence/conflicts: High for Thai NDI-hosted cHL indication; payer/access details remain unverified. 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
- ciltacabtagene autoleucel (Carvykti)[125]Approvedproteasome inhibitor, IMiD, and CD38-exposed/refractory context; Adult multiple myeloma after at least three prior lines including PI, IMiD, and anti-CD38 antibody, refractory to last treatment. · The CADTH summary states Carvykti should only be covered for patients with good performance status, without CNS myeloma/leptomeningeal involvement, without prior BCMA-targeted therapy, and without prior CAR-T therapy, and only when prescribed/administered in a hospital setting with adequate resources by MM specialists, with a price-reduction condition. Provincial implementation may differ from a national reimbursement recommendation. Confidence/conflicts: High for CADTH recommendation text as fetched; current provincial funding and newer earlier-line Health Canada/CDA-AMC changes remain refresh gaps. No conflict identified.
- daratumumab subcutaneous (Darzalex SC) with lenalidomide-dexamethasone; daratumumab subcutaneous maintenance after combination therapy[126]ApprovedCD38-targeted monoclonal antibody context; Newly diagnosed transplant-ineligible multiple myeloma with good performance status; relapsed or refractory multiple myeloma after at least one prior line; maintenance after completion of combination therapy. · CCO funding and regimen information may not apply to every patient. CCO notes different daratumumab products are not interchangeable and refers to NDFP forms for funded-regimen details. Confidence/conflicts: High for Ontario formulary/funding listing; province-by-province Canadian access and exact NDFP criteria remain gaps. No conflict identified. Availability/reimbursement outside the approving regulator not established.
- teclistamab (Tecvayli)[127]Conditionally approvedBCMA-targeted bispecific antibody context; Relapsed or refractory multiple myeloma; Ontario regimen page includes ramp-up and subsequent teclistamab treatment phases. · Cancer Care Ontario states formulary information is for health professionals and that funding information does not apply to all patients. The regimen notes inpatient admission may be required for cytokine-release-syndrome monitoring during ramp-up/early treatment, and the drug monograph directs users to the product monograph for the full approved indication. Confidence/conflicts: High for Ontario formulary/funding listing and Health Canada approval-status signal; exact product-monograph indication and province-by-province Canadian funding remain gaps. No conflict identified.
India
- daratumumab subcutaneous (Darzalex SC)[128]ApprovedCD38-targeted monoclonal antibody context; Newly diagnosed transplant-ineligible MM; newly diagnosed transplant-eligible MM with bortezomib-thalidomide-dexamethasone; MM after at least one prior therapy; relapsed/refractory MM after prior PI and IMiD. · The source is a CDSCO approval-list PDF and does not establish reimbursement, price, hospital formulary status, or patient eligibility. The same PDF lists product strength and formulation but should not be used as a dosing instruction. Confidence/conflicts: High for India CDSCO-listed approval contexts; payer/availability gap remains. No conflict identified.
- daratumumab subcutaneous with bortezomib, lenalidomide, and dexamethasone (D-VRd)[129]ApprovedCD38-targeted monoclonal antibody plus PI/IMiD context; Newly diagnosed multiple myeloma in adults eligible for autologous stem-cell transplant. · This is an SEC recommendation for grant of approval, not a final marketing authorization document. The source states the firm requested a local clinical-trial waiver and that the proposed indication is approved in multiple countries; final CDSCO marketing-authorization status and product-information text should be verified before treating it as currently available. Confidence/conflicts: Medium-high for SEC recommendation; final approval document not fetched. No conflict identified, but status should be refreshed. Availability/reimbursement outside the approving regulator not established.
- teclistamab (Tecvayli)[130]ApprovedBCMA-targeted bispecific antibody context; prior IMiD, PI, and anti-CD38 exposure; Adult relapsed and refractory multiple myeloma after at least three prior therapies including IMiD, PI, and anti-CD38 antibody, with progression on last therapy. · The CDSCO list verifies Indian regulatory approval/import-marketing permission, not insurance coverage, hospital formulary availability, or center capability. A separate CDSCO permission letter documents a Phase IV teclistamab safety study in Indian participants, reinforcing that post-approval safety data collection is required/ongoing. Confidence/conflicts: High for CDSCO approval and Phase IV trial-permission context. No payer coverage source fetched. No conflict identified. Availability/reimbursement outside the approving regulator not established.
Multiple
- denosumab and bisphosphonate options for myeloma bone disease[131]Established standard of carenot biomarker-specific; Supportive management of myeloma-related bone disease, including renal-impairment considerations. · International guideline context does not establish approval or reimbursement in any single country. Calcium/vitamin D supplementation, dental review, renal monitoring, and discontinuation planning must be individualized by clinicians. Confidence/conflicts: Medium-high because one source is a guideline summary; direct Lancet Oncology guideline PDF should be captured in a later pass. No conflict identified.
- infection-prevention supportive care including vaccination, antimicrobial prophylaxis, infection-control measures, and immunoglobulin replacement in selected contexts[132]Standard option (per The Lancet Haematology / IMWG authors)not biomarker-specific; Infection prevention across the multiple myeloma disease course; risk varies with disease-related immune dysfunction and treatment-related immunosuppression. · This is international consensus guidance, not a country-specific coverage rule. Vaccine timing, antimicrobial prophylaxis, antiviral prophylaxis, and immunoglobulin replacement require local clinician review, infection history, therapy regimen, and lab context. Confidence/conflicts: High for international infection-prevention strategy categories; country-level reimbursement and exact regimen-specific prophylaxis remain gaps. No conflict identified.
- renal-supportive management including rapid anti-myeloma therapy plus calcium/hypercalcemia management and bone-agent selection[133]Standard option (per National Cancer Institute)not biomarker-specific; Multiple myeloma with renal impairment or kidney insufficiency; bone disease/hypercalcemia supportive-care context. · These sources do not define eligibility for any individual patient and do not replace nephrology/hematology assessment. The NCI source is a clinical-trial description, not a routine-care recommendation. Confidence/conflicts: High for renal-impairment supportive-care caveats; routine-treatment availability of denosumab varies by jurisdiction and payer. No conflict identified.
- venous thromboembolism prophylaxis risk assessment and antithrombotic prophylaxis options[134]Standard option (per International Myeloma Foundation / IMWG)not biomarker-specific; IMiD-associated thrombosis context; Supportive thrombosis-prevention planning for patients receiving IMiD-containing myeloma regimens. · Antithrombotic selection depends on individualized clotting and bleeding risk, renal function, drug interactions, platelet count, and local protocols. This entry does not provide dosing or individualized anticoagulation advice. Confidence/conflicts: High for need for VTE risk assessment/prophylaxis with IMiD therapy; exact prophylaxis varies by risk and local protocol. No conflict identified.
출처
- FDA — approval notice (nivolumab with chemotherapy, untreated Hodgkin lymphoma) · FDA regulator approval notice
- EMA EPAR — Adcetris (brentuximab vedotin) · EMA EPAR
- EMA EPAR — Keytruda (pembrolizumab) · EMA EPAR
- NICE TA1059 · NICE health technology appraisal
- FDA — accelerated approval notice (epcoritamab-bysp, R/R DLBCL) · FDA regulator approval notice
- FDA — accelerated approval notice (glofitamab-gxbm, R/R LBCL) · FDA regulator approval notice
- EMA EPAR — Polivy (polatuzumab vedotin) · EMA EPAR
- EMA EPAR — Columvi (glofitamab) · EMA EPAR
- NCI PDQ — Aggressive B-cell Lymphoma Treatment · NCI PDQ
- FDA — DISCO Burst Edition: approval of Lunsumio (mosunetuzumab-axgb) · FDA regulator approval explainer
- FDA — approval notice (epcoritamab-bysp, follicular lymphoma) · FDA regulator approval notice
- NCI PDQ — Indolent B-cell Lymphoma Treatment · NCI PDQ
- FDA — approval notice (acalabrutinib with bendamustine and rituximab, untreated MCL) · FDA regulator approval notice
- FDA — accelerated approval notice (pirtobrutinib, R/R MCL) · FDA regulator approval notice
- EMA EPAR — Tecartus (brexucabtagene autoleucel) · EMA EPAR
- EMA EPAR — Imbruvica (ibrutinib) · EMA EPAR
- FDA — approval notice (teclistamab in combination with daratumumab hyaluronidase-fihj) · FDA regulator approval notice
- EMA EPAR — Darzalex (daratumumab) · EMA EPAR
- EMA EPAR — Carvykti (ciltacabtagene autoleucel) · EMA EPAR
- NICE TA1015 · NICE health technology appraisal
- U.S. Food and Drug Administration (FDA) — regulator approval explainer · regulator approval explainer
- U.S. Food and Drug Administration (FDA) — official drug label · official drug label
- NSSG / British Society for Haematology-linked supportive care guideline PDF — UK supportive-care guideline PDF for myeloma · UK supportive-care guideline PDF for myeloma
- American Society of Clinical Oncology (ASCO) / Journal of Clinical Oncology — ASCO clinical practice guideline update on bone-modifying agents in MM · ASCO clinical practice guideline update on bone-modifying agents in MM
- European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
- European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
- European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
- Haute Autorite de Sante (HAS) — France HAS reimbursement opinion page for Adcetris in Hodgkin lymphoma · France HAS reimbursement opinion page for Adcetris in Hodgkin lymphoma
- Takeda — Company press release reporting European Commission approval of Adcetris plus ECADD · Company press release reporting European Commission approval of Adcetris plus ECADD
- Haute Autorite de Sante (HAS) — France HAS reimbursement reassessment page · France HAS reimbursement reassessment page
- Gemeinsamer Bundesausschuss (G-BA) — Germany AMNOG benefit-assessment procedure page · Germany AMNOG benefit-assessment procedure page
- Gemeinsamer Bundesausschuss (G-BA) — Germany G-BA Annex XII resolution for ciltacabtagene autoleucel in multiple myeloma · Germany G-BA Annex XII resolution for ciltacabtagene autoleucel in multiple myeloma
- Haute Autorite de Sante (HAS) — France HAS page for Carvykti in multiple myeloma · France HAS page for Carvykti in multiple myeloma
- Onkopedia / DGHO-associated guideline platform — German guideline for HIV-associated lymphomas · German guideline for HIV-associated lymphomas
- Gemeinsamer Bundesausschuss (G-BA) — Germany G-BA courtesy-translation resolution for glofitamab in R/R DLBCL · Germany G-BA courtesy-translation resolution for glofitamab in R/R DLBCL
- Haute Autorite de Sante (HAS) — France HAS reimbursement opinion summary for COLUMVI in DLBCL NOS · France HAS reimbursement opinion summary for COLUMVI in DLBCL NOS
- Gemeinsamer Bundesausschuss (G-BA) — Germany G-BA courtesy-translation resolution for mosunetuzumab in R/R FL · Germany G-BA courtesy-translation resolution for mosunetuzumab in R/R FL
- Haute Autorite de Sante (HAS) — France HAS reimbursement opinion summary for LUNSUMIO in FL · France HAS reimbursement opinion summary for LUNSUMIO in FL
- Gemeinsamer Bundesausschuss (G-BA) — German benefit-assessment procedure page for nivolumab in Hodgkin lymphoma · German benefit-assessment procedure page for nivolumab in Hodgkin lymphoma
- Bristol Myers Squibb — Company press release reporting European Commission label expansion for Opdivo in frontline advanced cHL · Company press release reporting European Commission label expansion for Opdivo in frontline advanced cHL
- Gemeinsamer Bundesausschuss (G-BA) — Germany AMNOG benefit-assessment procedure page · Germany AMNOG benefit-assessment procedure page
- Haute Autorite de Sante (HAS) — France HAS reimbursement opinion page in English · France HAS reimbursement opinion page in English
- Gemeinsamer Bundesausschuss (G-BA) — Germany G-BA courtesy-translation justification for Polivy R/R DLBCL reassessment · Germany G-BA courtesy-translation justification for Polivy R/R DLBCL reassessment
- Haute Autorite de Sante (HAS) — France HAS reimbursement opinion summary for POLIVY in previously untreated DLBCL · France HAS reimbursement opinion summary for POLIVY in previously untreated DLBCL
- Gemeinsamer Bundesausschuss (G-BA) — Germany G-BA courtesy-translation justification for teclistamab in multiple myeloma · Germany G-BA courtesy-translation justification for teclistamab in multiple myeloma
- Haute Autorite de Sante (HAS) — France HAS reimbursement reassessment page for Tecvayli in multiple myeloma · France HAS reimbursement reassessment page for Tecvayli in multiple myeloma
- Haute Autorite de Sante (HAS) — France HAS reimbursement opinion for Kymriah in follicular lymphoma · France HAS reimbursement opinion for Kymriah in follicular lymphoma
- National Institute for Health and Care Excellence (NICE) — clinical guideline · clinical guideline
- National Institute for Health and Care Excellence (NICE) — clinical guideline · clinical guideline
- National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
- National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
- National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
- National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
- National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
- NICE — technology appraisal guidance · technology appraisal guidance
- NSSG / Oxford Haematology — UK regional myeloma bone-protection protocol PDF · UK regional myeloma bone-protection protocol PDF
- National Institute for Health and Care Excellence (NICE) — NICE technology appraisal TA524 for brentuximab vedotin in CD30+ Hodgkin lymphoma · NICE technology appraisal TA524 for brentuximab vedotin in CD30+ Hodgkin lymphoma
- National Institute for Health and Care Excellence (NICE) — NICE technology appraisal TA1059 for brentuximab vedotin in untreated stage 3/4 CD30+ Hodgkin lymphoma · NICE technology appraisal TA1059 for brentuximab vedotin in untreated stage 3/4 CD30+ Hodgkin lymphoma
- National Institute for Health and Care Excellence (NICE) — NICE technology appraisal TA462 for nivolumab in relapsed/refractory cHL · NICE technology appraisal TA462 for nivolumab in relapsed/refractory cHL
- National Institute for Health and Care Excellence (NICE) — NICE technology appraisal TA967 for pembrolizumab in relapsed/refractory cHL · NICE technology appraisal TA967 for pembrolizumab in relapsed/refractory cHL
- Pharmaceuticals and Medical Devices Agency (PMDA) — regulator approved-drug list · regulator approved-drug list
- Gilead / Kite — Company announcement reporting Japan Yescarta approval expansion in R/R LBCL · Company announcement reporting Japan Yescarta approval expansion in R/R LBCL
- GSK — Company press release reporting Japan MHLW approval for Blenrep combinations in R/R MM · Company press release reporting Japan MHLW approval for Blenrep combinations in R/R MM
- Takeda Oncology — Company announcement with Japan Adcetris approval-summary section · Company announcement with Japan Adcetris approval-summary section
- Pharmaceuticals and Medical Devices Agency (PMDA) — Japan PMDA English review report for Carvykti/ciltacabtagene autoleucel · Japan PMDA English review report for Carvykti/ciltacabtagene autoleucel
- Pharmaceuticals and Medical Devices Agency (PMDA) — Japan PMDA English review report for Darzalex untreated multiple myeloma indication · Japan PMDA English review report for Darzalex untreated multiple myeloma indication
- Pharmaceuticals and Medical Devices Agency (PMDA) — Japan PMDA English review report for Darzalex in relapsed/refractory multiple myeloma · Japan PMDA English review report for Darzalex in relapsed/refractory multiple myeloma
- RAD-AR Council / Kusuri-no-Shiori — Japan English patient drug-information sheet for Elrexfio S.C. Injection · Japan English patient drug-information sheet for Elrexfio S.C. Injection
- Pharmaceuticals and Medical Devices Agency (PMDA) — Japan PMDA English review report for Imbruvica treatment-naive MCL indication · Japan PMDA English review report for Imbruvica treatment-naive MCL indication
- Pharmaceuticals and Medical Devices Agency (PMDA) — Japan PMDA English review report for Abecma partial-change application · Japan PMDA English review report for Abecma partial-change application
- Pharmaceuticals and Medical Devices Agency (PMDA) / MHLW — PMDA English review report for Breyanzi partial-change approval · PMDA English review report for Breyanzi partial-change approval
- Chugai Pharmaceutical — Company launch announcement with MHLW approval and NHI listing details for Lunsumio in Japan · Company launch announcement with MHLW approval and NHI listing details for Lunsumio in Japan
- Pharmaceuticals and Medical Devices Agency (PMDA) — Japan PMDA English review report for Jaypirca · Japan PMDA English review report for Jaypirca
- Pharmaceuticals and Medical Devices Agency (PMDA) — Japan PMDA English review report for Rituxan · Japan PMDA English review report for Rituxan
- Pharmaceuticals and Medical Devices Agency (PMDA) — regulator approved-drug list · regulator approved-drug list
- Health Insurance Review and Assessment Service (HIRA) — Korea HIRA 2026 Cancer Disease Review Committee reimbursement-criteria results · Korea HIRA 2026 Cancer Disease Review Committee reimbursement-criteria results
- Health Insurance Review and Assessment Service (HIRA) — Korea HIRA Cancer Disease Review Committee reimbursement-criteria results · Korea HIRA Cancer Disease Review Committee reimbursement-criteria results
- Health Insurance Review and Assessment Service (HIRA) — Korea HIRA 2025 8th Cancer Disease Deliberation Committee results · Korea HIRA 2025 8th Cancer Disease Deliberation Committee results
- Dailypharm Korea — Korea pharmaceutical news report of MFDS Lunsumio approval · Korea pharmaceutical news report of MFDS Lunsumio approval
- Health Insurance Review and Assessment Service (HIRA) — Korea HIRA Pharmaceutical Reimbursement Evaluation Committee result · Korea HIRA Pharmaceutical Reimbursement Evaluation Committee result
- Health Insurance Review and Assessment Service (HIRA) — Korea HIRA 2026 Drug Reimbursement Evaluation Committee result · Korea HIRA 2026 Drug Reimbursement Evaluation Committee result
- Korea Citation Index / Cancer Research and Treatment — Korean multicenter peer-reviewed article landing page · Korean multicenter peer-reviewed article landing page
- Frontiers in Oncology / Catholic University of Korea authors — peer-reviewed Korean multi-center retrospective article · peer-reviewed Korean multi-center retrospective article
- Antengene via PR Newswire — Company press release reporting South Korea NHIS reimbursement for XPOVIO in R/R MM · Company press release reporting South Korea NHIS reimbursement for XPOVIO in R/R MM
- OncLive — Secondary oncology news report of South Korea MFDS approval for selinexor plus bortezomib/dexamethasone · Secondary oncology news report of South Korea MFDS approval for selinexor plus bortezomib/dexamethasone
- Health Insurance Review and Assessment Service (HIRA) — Korea HIRA FAQ for tisagenlecleucel reimbursement criteria · Korea HIRA FAQ for tisagenlecleucel reimbursement criteria
- Myeloma Australia Medical and Scientific Advisory Group — Australian practice statement on infection prevention in MM · Australian practice statement on infection prevention in MM
- Therapeutic Goods Administration (TGA) — Australia ARTG registration entry for Carvykti · Australia ARTG registration entry for Carvykti
- eviQ / Cancer Institute NSW — Australian multiple myeloma DVd protocol overview · Australian multiple myeloma DVd protocol overview
- eviQ / Cancer Institute NSW — Australian oncology protocol overview for Burkitt lymphoma dm R-CODOX-M/R-IVAC · Australian oncology protocol overview for Burkitt lymphoma dm R-CODOX-M/R-IVAC
- Therapeutic Goods Administration (TGA) — Australia AusPAR for Elrexfio/elranatamab · Australia AusPAR for Elrexfio/elranatamab
- eviQ / Cancer Institute NSW — Australian multiple myeloma RVd protocol overview · Australian multiple myeloma RVd protocol overview
- Therapeutic Goods Administration (TGA) — Australia public summary for provisional registration of Tecvayli · Australia public summary for provisional registration of Tecvayli
- China Anti-Cancer Association (CACA) Lymphoma Committee / Holistic Integrative Oncology — China lymphoma guideline, open-access peer-reviewed guideline article · China lymphoma guideline, open-access peer-reviewed guideline article
- National Medical Products Administration (NMPA) / CCFDIE — China regulator news page for conditional approval of ciltacabtagene autoleucel · China regulator news page for conditional approval of ciltacabtagene autoleucel
- National Medical Products Administration (NMPA) / CCFDIE — China regulator news page for glofitamab conditional approval · China regulator news page for glofitamab conditional approval
- Innovent Biologics / Lilly via PR Newswire — Company press release reporting China NMPA approval history for Jaypirca · Company press release reporting China NMPA approval history for Jaypirca
- Lupeng Pharmaceutical via PR Newswire — Company press release reporting China NMPA accelerated approval · Company press release reporting China NMPA accelerated approval
- National Healthcare Security Administration (NHSA) — China NRDL adjustment public application material for selinexor · China NRDL adjustment public application material for selinexor
- Antengene — Chinese-language company announcement reporting NMPA approval for XPOVIO XVd indication · Chinese-language company announcement reporting NMPA approval for XPOVIO XVd indication
- Antengene via PR Newswire — Company press release reporting China NMPA conditional approval for XPOVIO in R/R MM · Company press release reporting China NMPA conditional approval for XPOVIO in R/R MM
- OncLive — Secondary oncology news report of China NMPA conditional approval · Secondary oncology news report of China NMPA conditional approval
- Medthority — Secondary medical-news report of China NMPA approval for Tecvayli · Secondary medical-news report of China NMPA approval for Tecvayli
- MedElement clinical recommendations portal / Russian Hodgkin lymphoma clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
- MedElement clinical recommendations portal / Russian follicular lymphoma clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
- MedElement clinical recommendations portal / Russian multiple myeloma clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
- MedElement mirror of Russian Federation clinical recommendations — Russia 2024 clinical recommendations for CAR-T and radiation contexts in aggressive B-cell lymphomas · Russia 2024 clinical recommendations for CAR-T and radiation contexts in aggressive B-cell lymphomas
- MedElement clinical recommendations portal / Russian mantle cell lymphoma clinical recommendations mirror — Russian clinical guideline mirror · Russian clinical guideline mirror
- blood.ru / Russian hematology guideline document host — Russian-language multiple myeloma clinical guideline PDF · Russian-language multiple myeloma clinical guideline PDF
- Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — package insert PDF / regulator drug-information repository · package insert PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — product information PDF / regulator drug-information repository · product information PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — local product information PDF / regulator drug-information repository · local product information PDF / regulator drug-information repository
- Thai National Drug Information / Thai FDA-MOPH — controlled-use criteria / national medicines access PDF · controlled-use criteria / national medicines access PDF
- Thai National Drug Information / Thai FDA-MOPH — package leaflet PDF / regulator drug-information repository · package leaflet PDF / regulator drug-information repository
- Thai FDA / National Drug Information — Thai NDI-hosted Adcetris product information PDF · Thai NDI-hosted Adcetris product information PDF
- Thai FDA / National Drug Information — Thailand NDI-hosted Darzalex SC English product information · Thailand NDI-hosted Darzalex SC English product information
- Thai FDA / National Drug Information — Thai NDI-hosted Imbruvica English physician product information · Thai NDI-hosted Imbruvica English physician product information
- Thai FDA / National Drug Information — Thai NDI-hosted Keytruda product information PDF · Thai NDI-hosted Keytruda product information PDF
- Canadian Journal of Health Technologies / CADTH — Canada reimbursement recommendation for ciltacabtagene autoleucel · Canada reimbursement recommendation for ciltacabtagene autoleucel
- Ontario Health / Cancer Care Ontario — Ontario regimen monograph for DARADEXALENA(SC) · Ontario regimen monograph for DARADEXALENA(SC)
- Ontario Health / Cancer Care Ontario — Ontario regimen monograph for TECL/TECL(RAMP) · Ontario regimen monograph for TECL/TECL(RAMP)
- Central Drugs Standard Control Organisation (CDSCO) — India list of new drugs of r-DNA origin approved for import/manufacture and marketing, including daratumumab SC · India list of new drugs of r-DNA origin approved for import/manufacture and marketing, including daratumumab SC
- Central Drugs Standard Control Organisation (CDSCO) Subject Expert Committee (Oncology) — India SEC recommendation for daratumumab SC D-VRd additional indication · India SEC recommendation for daratumumab SC D-VRd additional indication
- Central Drugs Standard Control Organisation (CDSCO) — India CT-06 permission for Phase IV teclistamab study · India CT-06 permission for Phase IV teclistamab study
- Multiple Myeloma Hub summary of IMWG guidance — Guideline summary for IMWG myeloma-related bone disease recommendations · Guideline summary for IMWG myeloma-related bone disease recommendations
- The Lancet Haematology / IMWG authors — Peer-reviewed IMWG infection-prevention consensus abstract · Peer-reviewed IMWG infection-prevention consensus abstract
- National Cancer Institute (NCI) — NCI clinical trial description for denosumab in MM with kidney insufficiency · NCI clinical trial description for denosumab in MM with kidney insufficiency
- International Myeloma Foundation / IMWG — IMWG guideline resource for prevention of thalidomide/lenalidomide-associated thrombosis · IMWG guideline resource for prevention of thalidomide/lenalidomide-associated thrombosis
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.
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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
- camrelizumab + epirubicin/vincristine/dacarbazine임상시험 · NCT04067037임상시험In clinical trials (NCT04067037)China · first-line advanced classic Hodgkin lymphoma · Active, not recruiting (China sites). Trial registration is not an approval, reimbursement, or eligibility statement. ClinicalTrials.gov — NCT04067037
- epcoritamab + rituximab + lenalidomide (R2)임상시험 · NCT06191744임상시험In clinical trials (NCT06191744)Korea · previously untreated or previously treated follicular lymphoma · Recruiting (Korea-China sites). Trial registration is not an MFDS approval or eligibility statement. ClinicalTrials.gov — NCT06191744
- elranatamab (Elrexfio)임상시험 · NCT04798586임상시험In clinical trials (NCT04798586)relapsed or refractory multiple myeloma after at least three prior therapies (Japan and multinational sites) · Completed (Japan/multinational sites). A BCMA x CD3 bispecific; trial registration is not a PMDA approval or eligibility statement. ClinicalTrials.gov — NCT04798586
- Aggressive multidrug chemotherapy regimens; rituximab plus aggressive combination chemotherapy; CNS prophylaxis with methotrexate, usually intrathecal injections; pediatric risk-stratified regimens including LMB/BFM-style chemotherapy and rituximab-containing therapy in higher-risk groups; recurrent/refractory treatment options including reinduction/intensive therapy before HSCT as source-discussed contexts임상시험임상시험InvestigationalUnited States · MYC rearrangement characteristic context; CD20 relevant to rituximab-containing regimens; CNS involvement/prophylaxis setting relevant; no actionable mutation biomarker stated; Adult Burkitt/diffuse small noncleaved-cell lymphoma; pediatric newly diagnosed Burkitt lymphoma risk groups; recurrent or refractory pediatric Burkitt lymphoma; CNS prophylaxis for Burkitt lymphoma. · NCI PDQ is an evidence summary and does not establish product-specific FDA label status, payer coverage, local protocol details, center capability, or individual eligibility. Regimen names and exact components must be verified against institutional protocols. Recurrent/refractory pediatric Burkitt lymphoma has no standard option in the NCI childhood PDQ. Confidence/conflicts: High for NCI-described treatment categories; no conflict identified. National Cancer Institute (NCI) — national cancer agency evidence summary
- KTE-X19 / brexucabtagene autoleucel-like CAR-T study product (Tecartus-related construct)임상시험 · NCT06253663임상시험InvestigationalJapan · CD19-directed CAR-T investigational context; cyclin D1 overexpression or t(11;14) documentation required by protocol; Protocol MCL cohort required pathologically confirmed MCL, relapsed/refractory disease, up to five prior regimens, and prior anthracycline/bendamustine/high-dose cytarabine-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and BTK inhibitor. · This is a completed-recruitment clinical study, not a Japan PMDA approval or routine access statement for Tecartus in MCL. Trial participation would depend on protocol eligibility, site status, and sponsor/investigator processes; the fetched record does not establish current enrollment availability. Confidence/conflicts: High for trial status and protocol summary; no Japan approval claim made. No conflict identified. Gilead Clinical Trials — Sponsor clinical-trial record for JKART-1 KTE-X19 in Japanese R/R MCL or B-ALL
- Mezigdomide plus bortezomib and dexamethasone (MeziVd) versus pomalidomide plus bortezomib and dexamethasone (PVd); elranatamab (PF-06863135) Japan-specific study record임상시험 · NCT05519085임상시험Trial only (NCT05519085)Japan · No mutation biomarker stated; prior lenalidomide exposure and measurable disease criteria stated in trial record; Relapsed or refractory multiple myeloma after 1 to 3 prior lines for NCT05519085; relapsed or refractory multiple myeloma after at least three prior therapies including PI, IMiD, and anti-CD38 antibody for NCT04798586. · Registry records do not establish PMDA approval, reimbursement, routine access, or individual eligibility. NCT04798586 is completed and is not an open access pathway. PMDA approved-drug list text extraction was source-pending in this cycle, so this Japan cell is trial-only. Confidence/conflicts: High for registry facts; PMDA approval-list cell remains a source-pending gap. ClinicalTrials.gov — clinical-trial registry
- Venetoclax; BGB-16673; ibrutinib plus rituximab임상시험 · NCT07387471임상시험Trial only (NCT07387471)Japan · Serum IgM measurable disease appears in registry eligibility; no mutation biomarker required by the fetched records; Relapsed/refractory WM/LPL after at least one prior standard therapy for NCT07387471; B-cell malignancy including relapsed/refractory WM and BTK-inhibitor context for NCT05006716; treatment-naive or relapsed/refractory symptomatic WM for NCT04062448. · Registry records do not establish PMDA approval, Japanese reimbursement, routine availability, active enrollment beyond stated site statuses, or individual eligibility. NCT04062448 is completed. Confidence/conflicts: High for registry facts; no local approval claim made. ClinicalTrials.gov — clinical-trial registry
- teclistamab (Tecvayli)임상시험임상시험Trial only (registry)Japan · BCMA-targeted bispecific antibody context; Relapsed or refractory multiple myeloma clinical-trial setting in Japanese participants. · This verifies Japanese clinical-trial activity, not routine approval, NHI listing, or broad availability. Recruitment status, site participation, and protocol criteria must be checked directly with the trial site/jRCT current record. Confidence/conflicts: High for Japanese trial-registry existence; does not establish routine availability. No conflict identified. Japan Registry of Clinical Trials (jRCT) / Ministry of Health, Labour and Welfare — Japan clinical trial registry record for teclistamab in R/R MM
- BGB-16673; PRT2527 alone or with zanubrutinib or venetoclax; odronextamab; bortezomib-cytarabine-dexamethasone with pegteograstim; sonrotoclax plus zanubrutinib versus placebo plus zanubrutinib; ixazomib maintenance; XmAb13676/plamotamab; buparlisib임상시험 · NCT05006716임상시험Trial only (registry)Korea · CD20 relevant to plamotamab/XmAb13676 and odronextamab contexts; BTK/BCL2 pathway context for BGB-16673, zanubrutinib, venetoclax, and sonrotoclax; no mutation biomarker stated; Relapsed/refractory hematologic malignancies including MCL; previously treated B-cell NHL; newly diagnosed MCL; relapsed/refractory MCL; maintenance in newly diagnosed MCL. · Registry records do not establish MFDS approval, reimbursement, standard access, active enrollment unless stated, or individual eligibility. Some studies are completed or unknown-status and some are broader basket trials. Confidence/conflicts: Medium-high for registry records; no MFDS approval inferred. ClinicalTrials.gov — clinical-trial registry
- BGB-16673; epcoritamab plus rituximab plus lenalidomide with protocol comparator/combination components; odronextamab; bortezomib plus rituximab; rituximab SC/IV preference study components; surovatamig plus rituximab and standard immunochemotherapy regimens; idelalisib plus rituximab임상시험 · NCT05006716임상시험Trial only (registry)Korea · CD20 relevant to rituximab/obinutuzumab/epcoritamab/odronextamab contexts; CD3 relevant to epcoritamab/odronextamab; no mutation biomarker stated; Previously untreated follicular lymphoma; previously treated B-cell NHL including follicular lymphoma; relapsed/refractory B-cell NHL; CD20-positive follicular NHL grade 1 to 3A; previously treated indolent NHL. · Registry records do not establish MFDS approval, reimbursement, standard access, active enrollment unless stated, or individual eligibility. Some records are completed or terminated and some are broader B-cell NHL populations rather than follicular lymphoma-only. Confidence/conflicts: Medium-high for registry presence; no MFDS approval inferred. ClinicalTrials.gov — clinical-trial registry
- BGB-16673; nemtabrutinib; lenalidomide-bortezomib-rituximab-dexamethasone followed by lenalidomide maintenance임상시험 · NCT05006716임상시험Trial only (NCT05006716)Korea · Serum IgM measurable disease appears in R-VRD eligibility; no mutation biomarker required by the fetched records; B-cell malignancy including relapsed/refractory WM for BGB-16673; hematologic malignancies including WM for nemtabrutinib; WM meeting treatment criteria for R-VRD/maintenance. · Registry records do not establish MFDS approval, Korean reimbursement, routine access, or individual eligibility. NCT03697356 has an older last-update date than the other records and should be refreshed for current enrollment before patient-facing use. Confidence/conflicts: High for fetched registry fields; no local approval claim made. ClinicalTrials.gov — clinical-trial registry
- Brentuximab vedotin; DHAP chemotherapy components by study title context; pembrolizumab; doxorubicin; vinblastine; dacarbazine; cyclophosphamide; vincristine; prednisone/prednisolone; bleomycin; etoposide; radiotherapy; favezelimab/pembrolizumab; bendamustine; gemcitabine임상시험 · NCT05243693임상시험Trial only (registry)Korea · CD30-positive context for brentuximab vedotin registry; PD-(L)1-refractory context for favezelimab/pembrolizumab study; no mutation biomarker stated; Relapsed/refractory cHL; pediatric/young adult cHL; advanced classical Hodgkin lymphoma frontline study; PD-(L)1-refractory relapsed/refractory cHL. · Registry records do not establish MFDS approval, reimbursement, routine access, or individual eligibility. NCT05243693 has overall status unknown while the country query returned a recruiting Korea site; direct site confirmation is needed. Confidence/conflicts: Medium-high; exact Hodgkin condition support is strong, but NCT05243693 status needs direct site confirmation. ClinicalTrials.gov — clinical-trial registry
- Epcoritamab; mosunetuzumab; polatuzumab vedotin; tocilizumab; lenalidomide plus R-CHOP components; obinutuzumab-CHOP; rituximab-CHOP; PRT2527; zanubrutinib; venetoclax임상시험 · NCT03625037임상시험Trial only (registry)Korea · CD20/CD3 bispecific context for epcoritamab and mosunetuzumab; ABC-type DLBCL context for lenalidomide plus R-CHOP study; CD20-positive DLBCL context for GOYA study; Relapsed/progressive/refractory B-cell lymphoma including DLBCL/HGBCL/PMBCL; first-line post-immunochemotherapy consolidation and elderly/unfit previously untreated DLBCL; untreated ABC-type DLBCL; CD20-positive DLBCL. · Registry records do not establish MFDS approval, reimbursement, standard access, active enrollment unless stated, or individual eligibility. Several Korea records are completed or terminated. Confidence/conflicts: High for registry status and country-site presence; no regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
- Mezigdomide plus bortezomib and dexamethasone (MeziVd) versus pomalidomide plus bortezomib and dexamethasone (PVd)임상시험 · NCT05519085임상시험Trial only (NCT05519085)Korea · No mutation biomarker stated; prior lenalidomide exposure and measurable disease criteria stated; Relapsed or refractory multiple myeloma after 1 to 3 prior antimyeloma therapy lines, with prior lenalidomide exposure. · Registry listing does not establish MFDS approval, reimbursement, routine access, or individual eligibility. Some South Korea locations in the record are withdrawn, while several named sites are recruiting. Confidence/conflicts: High for registry facts; no regulator approval claim made. ClinicalTrials.gov — clinical-trial registry
- Autologous anti-CD19 CAR-engineered T cells with concurrent BTK inhibitor and fludarabine-based chemotherapy; CAR-T-CD19 cells with fludarabine-based chemotherapy; sepantronium bromide임상시험 · NCT05020392임상시험Trial only (NCT05020392)China · CD19-positive B-cell lymphoma required in CAR-T/BTK inhibitor trial; c-Myc rearranged high-grade B-cell lymphoma for sepantronium trial; Relapsed or refractory CD19-positive B-cell lymphoma including Burkitt lymphoma; relapsed/refractory c-Myc rearranged high-grade B-cell lymphoma. · Registry records do not establish NMPA approval, reimbursement, routine access, active enrollment beyond the listed site statuses, or individual eligibility. NCT05020392 overall status is unknown even though the China site line returned recruiting. Confidence/conflicts: Medium-high for registry trial facts; status caveat for NCT05020392 because overall and site-level status differ. ClinicalTrials.gov — clinical-trial registry
- BGB-16673; epcoritamab plus rituximab plus lenalidomide and protocol comparator/combination components; odronextamab; C402-CD19-CAR; zanubrutinib plus first-line chemoimmunotherapy; CD22-targeted CAR-T; anti-CD19 CAR-T with concurrent BTK inhibitor and fludarabine-based chemotherapy; HMPL-689; bortezomib plus rituximab; surovatamig plus rituximab and standard regimens임상시험 · NCT05006716임상시험Trial only (registry)China · CD19 for C402-CD19-CAR and CAR-T-CD19; CD22 for CD22-targeted CAR-T; CD20/CD3 for epcoritamab/odronextamab; no mutation biomarker stated; Previously untreated follicular lymphoma; previously treated B-cell NHL; relapsed/refractory B-cell lymphoma including follicular lymphoma grade 3B; grade 3A high-risk first-line follicular lymphoma; relapsed/refractory follicular lymphoma/marginal zone lymphoma. · Registry records do not establish NMPA approval, reimbursement, routine access, active enrollment unless stated, or individual eligibility. Several China records have unknown or completed status; some are broader B-cell lymphoma protocols. Confidence/conflicts: Medium-high for registry records; no NMPA approval inferred. ClinicalTrials.gov — clinical-trial registry
- BGB-16673; ibrutinib plus bendamustine and rituximab; orelabrutinib plus bendamustine and rituximab; CD22-targeted CAR-T; anti-CD19 CAR-T with BTK inhibitor and fludarabine-based chemotherapy; odronextamab; orelabrutinib plus rituximab with optional autologous HSCT and BEAM conditioning; competitive anti-CD19 CAR-T constructs with fludarabine/cyclophosphamide임상시험 · NCT05006716임상시험Trial only (registry)China · CD19 relevant to CAR-T protocols; CD22 relevant to CD22-targeted CAR-T; CD20/CD3 relevant to odronextamab; BTK pathway relevant to BGB-16673, orelabrutinib, ibrutinib, and BTK-inhibitor plus CAR-T contexts; Newly diagnosed/treatment-naive MCL; relapsed/refractory or recurrent MCL; broader B-cell malignancy/B-cell NHL protocols including MCL; optional autologous HSCT protocol context. · Registry records do not establish NMPA approval, reimbursement, routine access, active enrollment unless stated, or individual eligibility. Several records are unknown-status even when country-site query returned recruiting. Confidence/conflicts: Medium-high for registry records; no NMPA approval inferred. ClinicalTrials.gov — clinical-trial registry
- BGB-16673; nemtabrutinib; sonrotoclax with or without zanubrutinib; zanubrutinib plus bendamustine and rituximab; ibrutinib임상시험 · NCT05006716임상시험Trial only (NCT05006716)China · No mutation biomarker required by fetched records; prior BTK inhibitor, relapsed/refractory, untreated, and measurable disease settings vary by study; Relapsed/refractory or BTK-inhibitor-context B-cell malignancy including WM for BGB-16673; hematologic malignancies including WM for nemtabrutinib; relapsed/refractory or untreated WM cohorts for sonrotoclax/zanubrutinib; newly diagnosed WM for zanubrutinib-BR; relapsed/refractory WM for ibrutinib. · Registry records do not establish NMPA approval, China reimbursement, routine access, or individual eligibility. NCT05979948 has unknown overall status despite a recruiting site; completed studies do not imply current access. Confidence/conflicts: Medium-high for registry facts; unknown-status and completed-study caveats recorded. ClinicalTrials.gov — clinical-trial registry
- Camrelizumab; epirubicin; vincristine; dacarbazine임상시험 · NCT04067037임상시험Trial only (NCT04067037)China · No mutation biomarker stated; First-line advanced classical Hodgkin lymphoma. · Registry record does not establish NMPA approval, reimbursement, standard access, or individual eligibility. The study is active-not-recruiting, not an open recruiting option unless a site confirms otherwise. Confidence/conflicts: High for registry status and China-site presence; no NMPA approval inferred. ClinicalTrials.gov — clinical-trial registry
- GR1803 injection versus daratumumab plus pomalidomide and dexamethasone (DPd)임상시험 · NCT07452198임상시험Trial only (NCT07452198)China · No mutation biomarker stated; trial requires prior PI and lenalidomide exposure and measurable disease criteria as described in registry; Relapsed or refractory multiple myeloma after 1 to 3 prior antimyeloma therapy lines including a proteasome inhibitor and lenalidomide, with additional lenalidomide-refractory criteria for participants with one prior line. · Registry listing does not establish NMPA approval, reimbursement, routine access, or individual eligibility. GR1803 is recorded as a trial intervention, not as a verified approved therapy in this cell. Confidence/conflicts: High for registry facts; no conflict identified. ClinicalTrials.gov — clinical-trial registry
- Polatuzumab vedotin plus zanubrutinib and R-CHP components; CD19 CAR-T; glofitamab; C402-CD19-CAR; polatuzumab vedotin with rituximab, gemcitabine, and oxaliplatin; mitoxantrone hydrochloride liposome; bortezomib plus GDP임상시험 · NCT07608978임상시험Trial only (registry)China · MCD/BN2/N1 subtype context for polatuzumab-zanubrutinib trial; CD19 CAR-T contexts; no mutation biomarker stated for glofitamab observational record; Previously untreated molecular-subtype DLBCL; relapsed/refractory large B-cell lymphoma; second-line DLBCL; relapsed/refractory DLBCL transplant-ineligible salvage context. · Registry records do not establish NMPA approval, standard access, reimbursement, or individual eligibility. Some records are observational or investigational cell-therapy studies. Confidence/conflicts: High for registry status and China-site presence; no NMPA approval inferred. ClinicalTrials.gov — clinical-trial registry
- BCD-264 monotherapy versus daratumumab (Darzalex) monotherapy임상시험 · NCT06296121임상시험Trial only (NCT06296121)Russia · No mutation biomarker stated; prior proteasome inhibitor and immunomodulatory drug exposure required in registry eligibility; Relapsed and refractory multiple myeloma with prior proteasome inhibitor and immunomodulatory drug treatment and disease progression on prior therapy. · Registry listing does not establish Russian regulator approval, reimbursement, routine access outside trial, or individual eligibility. BCD-264 is recorded as an investigational comparator in this cell. Confidence/conflicts: High for registry facts; no conflict identified. ClinicalTrials.gov — clinical-trial registry
- Ibrutinib; idelalisib plus rituximab; idelalisib plus bendamustine and rituximab임상시험 · NCT01804686임상시험Trial only (NCT01804686)Russia · No mutation biomarker required by fetched Russia records; Long-term extension for participants already in an ibrutinib clinical study for NCT01804686; previously treated indolent NHL for idelalisib combination studies. · Registry records do not establish Russian regulator approval, reimbursement, routine access, active enrollment beyond stated site statuses, or individual eligibility. The idelalisib records are indolent-NHL studies, not dedicated WM-only studies, and are terminated. Confidence/conflicts: Medium for Russia because only one WM-including active extension record and broader terminated indolent-NHL records were verified; no local approval claim made. ClinicalTrials.gov — clinical-trial registry
- Nivolumab; doxorubicin; vinblastine; dacarbazine; pembrolizumab; nivolumab-DHAP context; ifosfamide; carboplatin; etoposide; bendamustine; gemcitabine; vinorelbine; PET-adapted N-AVD/N-EACOPD-14 contexts임상시험 · NCT06984146임상시험Trial only (registry)Russia · PD-(L)1-refractory/post-autoHCT contexts in selected records; no mutation biomarker stated; Advanced classic Hodgkin lymphoma; post-autologous HCT maintenance; relapsed/refractory Hodgkin lymphoma; PET-adapted first-line and salvage contexts. · Registry records do not establish Roszdravnadzor approval, reimbursement, routine access, or individual eligibility. Unknown-status studies with recruiting site rows require direct site confirmation. Confidence/conflicts: Medium-high; exact Hodgkin support and Russia sites are verified, but unknown-status records need direct confirmation. ClinicalTrials.gov — clinical-trial registry
- Pediatric mature B-cell NHL multiagent chemotherapy protocol components; tafasitamab plus lenalidomide plus R-CHOP; polatuzumab vedotin plus R-CHP; pixantrone plus rituximab; gemcitabine plus rituximab; lenalidomide plus R-CHOP; obinutuzumab-CHOP; rituximab-CHOP; R-DA-EPOCH-21 with or without autologous SCT; R-mNHL-BFM-90 with or without autologous SCT임상시험 · NCT05518383임상시험Trial only (registry)Russia · No mutation biomarker stated; high-risk/newly diagnosed and poor-prognosis DLBCL contexts in selected studies; Pediatric/adolescent mature B-cell NHL including DLBCL; newly diagnosed high-intermediate/high-risk DLBCL; untreated ABC-type DLBCL; relapsed aggressive B-cell NHL/DLBCL transplant-ineligible; poor-prognosis DLBCL with autologous SCT study context. · Registry records do not establish Roszdravnadzor approval, reimbursement, routine access, active enrollment unless stated, or individual eligibility. NCT02842931 has overall status unknown while the country query returned a recruiting Russia site. Confidence/conflicts: Medium-high; exact DLBCL support is verified, but NCT02842931 requires direct site confirmation. ClinicalTrials.gov — clinical-trial registry
- Pixantrone plus rituximab; gemcitabine plus rituximab; rituximab SC and IV with CHOP/CVP components; bortezomib plus rituximab; idelalisib plus rituximab; Aurixim; BI 695500 versus MabThera/rituximab임상시험 · NCT01321541임상시험Trial only (registry)Russia · CD20 relevant to rituximab and rituximab biosimilar studies; no mutation biomarker stated; Relapsed follicular grade 3 lymphoma not eligible for stem cell transplant; follicular NHL rituximab SC/IV; relapsed/refractory B-cell NHL; previously treated indolent NHL; first-line low-tumor-burden follicular lymphoma. · Registry records do not establish Roszdravnadzor approval, reimbursement, routine access, active enrollment, or individual eligibility. Most Russia records in this cell are completed or terminated and should be treated as historical trial evidence. Confidence/conflicts: High for registry records; no Roszdravnadzor approval inferred. ClinicalTrials.gov — clinical-trial registry
- TL-895 with or without navtemadlin; pirtobrutinib versus approved BTK inhibitors; ibrutinib, acalabrutinib, zanubrutinib; acalabrutinib plus bendamustine and rituximab; bortezomib-containing R-CHOP-like regimen; lenalidomide versus investigator's choice; temsirolimus; ibrutinib plus bendamustine and rituximab임상시험 · NCT02825836임상시험Trial only (registry)Russia · BTK pathway relevant to ibrutinib, acalabrutinib, zanubrutinib, pirtobrutinib, and TL-895; no mutation biomarker stated; Treatment-naive and relapsed/refractory B-cell malignancies including MCL; MCL BTK-inhibitor comparator context; previously untreated MCL; newly diagnosed MCL; relapsed/refractory MCL. · Registry records do not establish Roszdravnadzor approval, reimbursement, routine access, active enrollment unless stated, or individual eligibility. Several Russia records are completed or unknown-status. Confidence/conflicts: Medium-high for registry records; no Roszdravnadzor approval inferred. ClinicalTrials.gov — clinical-trial registry
- BCMA-targeted chimeric antigen receptor T cells (CAR-T)임상시험 · NCT07458659임상시험Trial only (NCT07458659)Thailand · BCMA-targeted CAR T-cell therapy context; no mutation biomarker stated; Relapsed/refractory multiple myeloma after at least three treatment lines, with prior proteasome inhibitor and immunomodulator treatment failure described in registry eligibility. · Registry listing does not establish Thai FDA approval, reimbursement, routine access, active enrollment, or individual eligibility. The overall status is not-yet-recruiting. Confidence/conflicts: High for registry facts; no regulator approval claim made. ClinicalTrials.gov — clinical-trial registry
- Brentuximab vedotin; CK-301/cosibelimab임상시험 · NCT01990534임상시험Trial only (registry)Thailand · No mutation biomarker stated; Relapsed/refractory Hodgkin lymphoma for brentuximab vedotin; advanced-cancer/classical Hodgkin lymphoma basket context for cosibelimab. · Registry records do not establish Thai FDA approval, reimbursement, routine access, or individual eligibility. The brentuximab study is completed, and the cosibelimab study is active-not-recruiting. Confidence/conflicts: High for registry location/status; no Thai regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
- Ibrutinib plus rituximab with lenalidomide/bortezomib comparator or combination context; rituximab-cyclophosphamide-doxorubicin-bortezomib-prednisone versus rituximab-cyclophosphamide-doxorubicin-vincristine-prednisone임상시험 · NCT05564052임상시험Trial only (registry)Thailand · BTK pathway relevant to ibrutinib; CD20 relevant to rituximab; no mutation biomarker stated; Relapsed or refractory MCL; newly diagnosed MCL. · Registry records do not establish Thai FDA approval, reimbursement, routine access, active enrollment, or individual eligibility. Both Thailand records in this cell are completed. Confidence/conflicts: High for registry records; no Thai FDA approval inferred. ClinicalTrials.gov — clinical-trial registry
- Odronextamab plus CHOP-like chemotherapy; rituximab-CHOP; tafasitamab plus lenalidomide plus R-CHOP; zilovertamab vedotin; ofatumumab-DHAP versus rituximab-DHAP followed by autologous stem cell transplant; obinutuzumab-CHOP versus rituximab-CHOP; rituximab SC/IV with CHOP임상시험 · NCT06091865임상시험Trial only (registry)Thailand · CD20-positive context for rituximab/obinutuzumab studies; no mutation biomarker stated; Previously untreated DLBCL; newly diagnosed high-intermediate/high-risk DLBCL; relapsed/refractory DLBCL; salvage chemoimmunotherapy followed by autologous SCT. · Registry records do not establish Thai FDA approval, reimbursement, standard access, active enrollment unless stated, or individual eligibility. Several studies are completed or terminated; odronextamab is investigational in this context. Confidence/conflicts: High for registry records; no Thai regulator approval inferred. ClinicalTrials.gov — clinical-trial registry
- Rituximab SC and IV with CHOP/CVP/bendamustine components; rituximab induction/maintenance; bortezomib plus rituximab; surovatamig plus rituximab versus R-CHOP/R-CVP/BR; odronextamab plus chemotherapy versus rituximab plus chemotherapy; rituximab maintenance in follicular NHL grade 3B/DLBCL protocol context임상시험 · NCT01200758임상시험Trial only (registry)Thailand · CD20-positive context for rituximab studies; CD20/CD3 relevant to surovatamig and odronextamab mechanisms; no mutation biomarker stated; Follicular NHL rituximab SC/IV; primary rituximab and maintenance; relapsed/refractory B-cell NHL; previously untreated follicular lymphoma; follicular lymphoma chemotherapy-combination trial context; follicular NHL grade 3B maintenance protocol context. · Registry records do not establish Thai FDA approval, reimbursement, routine access, active enrollment unless stated, or individual eligibility. Several Thailand studies are completed; NCT06097364 is active-not-recruiting, while NCT06549595 is recruiting. Confidence/conflicts: High for registry records; no Thai FDA approval inferred. ClinicalTrials.gov — clinical-trial registry
- Zanubrutinib (Brukinsa); copanlisib with standard immunochemotherapy including rituximab, bendamustine, cyclophosphamide, doxorubicin, vincristine, prednisone임상시험 · NCT02626455임상시험Trial only (NCT02626455)Thailand · No mutation biomarker required by fetched Thailand sources; Adult WM for zanubrutinib package-leaflet indication; relapsed indolent NHL including LPL/WM after prior anti-CD20-based immunochemotherapy and alkylating-agent exposure for NCT02626455. · The Thai FDA source is an English package leaflet hosted by the Thai National Drug Information system; reimbursement, hospital formulary access, and current registration status need a separate Thai regulator/database confirmation. NCT02626455 is terminated and does not show current trial access. Confidence/conflicts: Medium-high for package leaflet and registry facts; Thai registration/reimbursement remains a gap. Thai FDA / National Drug Information — regulator-hosted package leaflet
- elranatamab (Elrexfio/PF-06863135) monotherapy or elranatamab plus daratumumab versus daratumumab, pomalidomide, and dexamethasone임상시험임상시험InvestigationalIndia · BCMA-targeted bispecific antibody context; Relapsed/refractory multiple myeloma after at least one prior line including lenalidomide and a proteasome inhibitor. · This is clinical-trial permission, not a marketing approval or routine treatment listing. CDSCO states trial initiation requires ethics approval and CTRI registration, and that trial permission does not automatically lead to marketing permission. Confidence/conflicts: High for India CDSCO clinical-trial permission; current recruitment status requires CTRI/site verification. No conflict identified. Central Drugs Standard Control Organisation (CDSCO) — India CT-06 permission for elranatamab Phase 3 multiple myeloma trial
- iberdomide with daratumumab and dexamethasone (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd)임상시험임상시험Reported in a clinical trialIndia · cereblon E3 ligase modulator / immunomodulator context with daratumumab-based comparator; Relapsed or refractory multiple myeloma clinical-trial setting. · CDSCO explicitly states clinical trial permission does not imply future marketing permission in India. Site initiation requires ethics-committee approval, CTRI registration before first enrollment, and compliance with Indian clinical-trial rules. This is not routine-care availability. Confidence/conflicts: High for India CDSCO clinical-trial permission; current recruitment status requires CTRI/site verification. No conflict identified. Central Drugs Standard Control Organisation (CDSCO) — India CT-06 permission for EXCALIBER-RRMM iberdomide clinical trial
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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