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Sarcoma (incl. GIST): 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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임상시험 검색어

Sarcoma (incl. GIST) clinical trial

국가별 선택지

국가별 치료 선택지

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

United States

  • Active surveillance; surgery in selected abdominal-wall sporadic cases failing observation; medical therapies including chemotherapy, tyrosine kinase inhibitors, and gamma secretase inhibitors; local ablative treatments including cryotherapy or radiotherapy; pain control/supportive care[1]Standard option (per Desmoid Tumor Research Foundation)Familial adenomatous polyposis context noted by source; no treatment biomarker required; Initial observation and escalation after progression/symptoms or failure of observation, depending on tumor location and familial/sporadic context. · DTRF is a patient-advocacy source summarizing guideline approaches, not a regulator. Specific therapy availability and sequencing vary by country and specialist team. Confidence/conflicts: Medium-high for consensus-framework summary; regulator-specific drug availability must be captured separately.
  • Active surveillance; surgery in selected abdominal-wall sporadic cases failing observation; medical therapies including chemotherapy, tyrosine kinase inhibitors, and gamma secretase inhibitors; local ablative treatments including cryotherapy or radiotherapy; pain control/supportive care[1]Standard option (per Desmoid Tumor Research Foundation)Familial adenomatous polyposis context noted by source; no treatment biomarker required; Initial observation and escalation after progression/symptoms or failure of observation, depending on tumor location and familial/sporadic context. · DTRF is a patient-advocacy source summarizing guideline approaches, not a regulator. Specific therapy availability and sequencing vary by country and specialist team. Confidence/conflicts: Medium-high for consensus-framework summary; regulator-specific drug availability must be captured separately.
  • Active surveillance; surgery in selected abdominal-wall sporadic cases failing observation; medical therapies including chemotherapy, tyrosine kinase inhibitors, and gamma secretase inhibitors; local ablative treatments including cryotherapy or radiotherapy; pain control/supportive care[1]Standard option (per Desmoid Tumor Research Foundation)Familial adenomatous polyposis context noted by source; no treatment biomarker required; Initial observation and escalation after progression/symptoms or failure of observation, depending on tumor location and familial/sporadic context. · DTRF is a patient-advocacy source summarizing guideline approaches, not a regulator. Specific therapy availability and sequencing vary by country and specialist team. Confidence/conflicts: Medium-high for consensus-framework summary; regulator-specific drug availability must be captured separately.
  • Active surveillance; surgery in selected abdominal-wall sporadic cases failing observation; medical therapies including chemotherapy, tyrosine kinase inhibitors, and gamma secretase inhibitors; local ablative treatments including cryotherapy or radiotherapy; pain control/supportive care[1]Standard option (per Desmoid Tumor Research Foundation)Familial adenomatous polyposis context noted by source; no treatment biomarker required; Initial observation and escalation after progression/symptoms or failure of observation, depending on tumor location and familial/sporadic context. · DTRF is a patient-advocacy source summarizing guideline approaches, not a regulator. Specific therapy availability and sequencing vary by country and specialist team. Confidence/conflicts: Medium-high for consensus-framework summary; regulator-specific drug availability must be captured separately.
  • Active surveillance; surgery in selected abdominal-wall sporadic cases failing observation; medical therapies including chemotherapy, tyrosine kinase inhibitors, and gamma secretase inhibitors; local ablative treatments including cryotherapy or radiotherapy; pain control/supportive care[1]Standard option (per Desmoid Tumor Research Foundation)Familial adenomatous polyposis context noted by source; no treatment biomarker required; Initial observation and escalation after progression/symptoms or failure of observation, depending on tumor location and familial/sporadic context. · DTRF is a patient-advocacy source summarizing guideline approaches, not a regulator. Specific therapy availability and sequencing vary by country and specialist team. Confidence/conflicts: Medium-high for consensus-framework summary; regulator-specific drug availability must be captured separately.
  • Afamitresgene autoleucel (Tecelra); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[2]FDA accelerated approvalHLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive and tumor MAGE-A4 antigen expression for afamitresgene autoleucel; synovial sarcoma often has translocation biology in pediatric NCI PDQ context; Adults with unresectable or metastatic synovial sarcoma after prior chemotherapy and required HLA/MAGE-A4 testing for Tecelra; localized/advanced STS surgery/radiation/chemotherapy context from NCI. · FDA approval is accelerated and biomarker/device-gated; it does not imply eligibility, availability at every center, or insurance coverage. NCI PDQ STS sections are broad evidence summaries and not personalized recommendations. Confidence/conflicts: High for FDA accelerated approval and biomarker requirements; no current EMA/UK equivalent approval inferred.
  • Afamitresgene autoleucel (Tecelra); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[2]FDA accelerated approvalHLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive and tumor MAGE-A4 antigen expression for afamitresgene autoleucel; synovial sarcoma often has translocation biology in pediatric NCI PDQ context; Adults with unresectable or metastatic synovial sarcoma after prior chemotherapy and required HLA/MAGE-A4 testing for Tecelra; localized/advanced STS surgery/radiation/chemotherapy context from NCI. · FDA approval is accelerated and biomarker/device-gated; it does not imply eligibility, availability at every center, or insurance coverage. NCI PDQ STS sections are broad evidence summaries and not personalized recommendations. Confidence/conflicts: High for FDA accelerated approval and biomarker requirements; no current EMA/UK equivalent approval inferred.
  • Afamitresgene autoleucel (Tecelra); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[2]FDA accelerated approvalHLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive and tumor MAGE-A4 antigen expression for afamitresgene autoleucel; synovial sarcoma often has translocation biology in pediatric NCI PDQ context; Adults with unresectable or metastatic synovial sarcoma after prior chemotherapy and required HLA/MAGE-A4 testing for Tecelra; localized/advanced STS surgery/radiation/chemotherapy context from NCI. · FDA approval is accelerated and biomarker/device-gated; it does not imply eligibility, availability at every center, or insurance coverage. NCI PDQ STS sections are broad evidence summaries and not personalized recommendations. Confidence/conflicts: High for FDA accelerated approval and biomarker requirements; no current EMA/UK equivalent approval inferred.
  • Afamitresgene autoleucel (Tecelra); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[2]FDA accelerated approvalHLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive and tumor MAGE-A4 antigen expression for afamitresgene autoleucel; synovial sarcoma often has translocation biology in pediatric NCI PDQ context; Adults with unresectable or metastatic synovial sarcoma after prior chemotherapy and required HLA/MAGE-A4 testing for Tecelra; localized/advanced STS surgery/radiation/chemotherapy context from NCI. · FDA approval is accelerated and biomarker/device-gated; it does not imply eligibility, availability at every center, or insurance coverage. NCI PDQ STS sections are broad evidence summaries and not personalized recommendations. Confidence/conflicts: High for FDA accelerated approval and biomarker requirements; no current EMA/UK equivalent approval inferred.
  • Afamitresgene autoleucel (Tecelra); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[2]FDA accelerated approvalHLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive and tumor MAGE-A4 antigen expression for afamitresgene autoleucel; synovial sarcoma often has translocation biology in pediatric NCI PDQ context; Adults with unresectable or metastatic synovial sarcoma after prior chemotherapy and required HLA/MAGE-A4 testing for Tecelra; localized/advanced STS surgery/radiation/chemotherapy context from NCI. · FDA approval is accelerated and biomarker/device-gated; it does not imply eligibility, availability at every center, or insurance coverage. NCI PDQ STS sections are broad evidence summaries and not personalized recommendations. Confidence/conflicts: High for FDA accelerated approval and biomarker requirements; no current EMA/UK equivalent approval inferred.
  • Afamitresgene autoleucel (Tecelra); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[2]FDA accelerated approvalHLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive and tumor MAGE-A4 antigen expression for afamitresgene autoleucel; synovial sarcoma often has translocation biology in pediatric NCI PDQ context; Adults with unresectable or metastatic synovial sarcoma after prior chemotherapy and required HLA/MAGE-A4 testing for Tecelra; localized/advanced STS surgery/radiation/chemotherapy context from NCI. · FDA approval is accelerated and biomarker/device-gated; it does not imply eligibility, availability at every center, or insurance coverage. NCI PDQ STS sections are broad evidence summaries and not personalized recommendations. Confidence/conflicts: High for FDA accelerated approval and biomarker requirements; no current EMA/UK equivalent approval inferred.
  • Crizotinib (Xalkori)[3]FDA-approvedALK-positive; Unresectable, recurrent, or refractory ALK-positive IMT in adults and in pediatric patients age 1 year and older. · This FDA page verifies U.S. regulatory status only. It does not establish payer coverage, sequencing relative to surgery or other systemic therapy, or suitability for ALK-negative IMT. Confidence/conflicts: High for FDA approval scope and age/setting language; no conflict identified.
  • Eribulin mesylate (Halaven); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[4]FDA-approvedNo biomarker required by fetched sources; Unresectable or metastatic liposarcoma after prior anthracycline-containing regimen for eribulin; localized/advanced/recurrent adult STS contexts for surgery/radiation/systemic options. · Eribulin is liposarcoma-specific in the FDA label, but the NCI PDQ STS treatment categories are broader STS guidance and not a personalized recommendation. Exact histologic subtype and prior therapy matter. Confidence/conflicts: High for eribulin FDA label/news and NCI STS categories; current Halaven label refresh remains a gap.
  • Eribulin mesylate (Halaven); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[4]FDA-approvedNo biomarker required by fetched sources; Unresectable or metastatic liposarcoma after prior anthracycline-containing regimen for eribulin; localized/advanced/recurrent adult STS contexts for surgery/radiation/systemic options. · Eribulin is liposarcoma-specific in the FDA label, but the NCI PDQ STS treatment categories are broader STS guidance and not a personalized recommendation. Exact histologic subtype and prior therapy matter. Confidence/conflicts: High for eribulin FDA label/news and NCI STS categories; current Halaven label refresh remains a gap.
  • Eribulin mesylate (Halaven); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[4]FDA-approvedNo biomarker required by fetched sources; Unresectable or metastatic liposarcoma after prior anthracycline-containing regimen for eribulin; localized/advanced/recurrent adult STS contexts for surgery/radiation/systemic options. · Eribulin is liposarcoma-specific in the FDA label, but the NCI PDQ STS treatment categories are broader STS guidance and not a personalized recommendation. Exact histologic subtype and prior therapy matter. Confidence/conflicts: High for eribulin FDA label/news and NCI STS categories; current Halaven label refresh remains a gap.
  • Eribulin mesylate (Halaven); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[4]FDA-approvedNo biomarker required by fetched sources; Unresectable or metastatic liposarcoma after prior anthracycline-containing regimen for eribulin; localized/advanced/recurrent adult STS contexts for surgery/radiation/systemic options. · Eribulin is liposarcoma-specific in the FDA label, but the NCI PDQ STS treatment categories are broader STS guidance and not a personalized recommendation. Exact histologic subtype and prior therapy matter. Confidence/conflicts: High for eribulin FDA label/news and NCI STS categories; current Halaven label refresh remains a gap.
  • Nirogacestat (Ogsiveo)[5]FDA-approvedNo biomarker required by fetched FDA approval notice; Adults with progressing desmoid tumors requiring systemic treatment; DeFi trial enrolled progressing desmoid tumors not amenable to surgery. · FDA approval notice does not determine insurance coverage, local formulary access, or individual eligibility. FDA lists common adverse reactions and reproductive/ovarian toxicity concerns in the approval summary; dosing details are not reproduced here for patient-facing catalog use. Confidence/conflicts: High for FDA-approved U.S. indication; no claim about personal suitability or coverage.
  • Pexidartinib (Turalio); vimseltinib (Romvimza)[6]FDA-approvedCSF1R pathway targeted by pexidartinib and vimseltinib; no biomarker test requirement stated in fetched FDA approval notices; Adult symptomatic TGCT where surgery is not appropriate or may cause worsening functional limitation/severe morbidity. · FDA notes pexidartinib has a boxed warning for serious and potentially fatal liver injury and is available only through a REMS program. FDA approval notices do not establish payer coverage, local formulary access, or individual eligibility. Confidence/conflicts: High for U.S. approvals; no recommendation between approved options.
  • Surgery; multiagent chemotherapy including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, and etoposide contexts; pulmonary metastasectomy context where source discusses metastatic disease[7]Standard option (per NCI PDQ)No biomarker required by fetched NCI source; histologic response/necrosis after chemotherapy is discussed as a treatment-stratification research factor; Localized and metastatic osteosarcoma/UPS of bone contexts in NCI PDQ; surgery and perioperative multiagent chemotherapy. · NCI PDQ is an evidence summary, not personalized medical advice. Regimen choice, timing, resectability, metastatic-site surgery, age, organ function, and clinical-trial availability require specialist team discussion. Confidence/conflicts: High for NCI PDQ treatment framework; no drug-specific FDA approval claim made.
  • Surgery; multiagent chemotherapy including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, and etoposide contexts; pulmonary metastasectomy context where source discusses metastatic disease[7]Standard option (per NCI PDQ)No biomarker required by fetched NCI source; histologic response/necrosis after chemotherapy is discussed as a treatment-stratification research factor; Localized and metastatic osteosarcoma/UPS of bone contexts in NCI PDQ; surgery and perioperative multiagent chemotherapy. · NCI PDQ is an evidence summary, not personalized medical advice. Regimen choice, timing, resectability, metastatic-site surgery, age, organ function, and clinical-trial availability require specialist team discussion. Confidence/conflicts: High for NCI PDQ treatment framework; no drug-specific FDA approval claim made.
  • Surgery; multiagent chemotherapy including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, and etoposide contexts; pulmonary metastasectomy context where source discusses metastatic disease[7]Standard option (per NCI PDQ)No biomarker required by fetched NCI source; histologic response/necrosis after chemotherapy is discussed as a treatment-stratification research factor; Localized and metastatic osteosarcoma/UPS of bone contexts in NCI PDQ; surgery and perioperative multiagent chemotherapy. · NCI PDQ is an evidence summary, not personalized medical advice. Regimen choice, timing, resectability, metastatic-site surgery, age, organ function, and clinical-trial availability require specialist team discussion. Confidence/conflicts: High for NCI PDQ treatment framework; no drug-specific FDA approval claim made.
  • Surgery; multiagent chemotherapy including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, and etoposide contexts; pulmonary metastasectomy context where source discusses metastatic disease[7]Standard option (per NCI PDQ)No biomarker required by fetched NCI source; histologic response/necrosis after chemotherapy is discussed as a treatment-stratification research factor; Localized and metastatic osteosarcoma/UPS of bone contexts in NCI PDQ; surgery and perioperative multiagent chemotherapy. · NCI PDQ is an evidence summary, not personalized medical advice. Regimen choice, timing, resectability, metastatic-site surgery, age, organ function, and clinical-trial availability require specialist team discussion. Confidence/conflicts: High for NCI PDQ treatment framework; no drug-specific FDA approval claim made.
  • Surgery; radiation therapy; chemotherapy including doxorubicin/ifosfamide contexts; pazopanib (Votrient)[8]FDA-approvedNo biomarker required by fetched sources; Localized/resectable STS settings for surgery/radiation/chemotherapy; advanced STS after prior chemotherapy for pazopanib label. · These are adult STS sources rather than leiomyosarcoma-only approvals. Pazopanib label excludes demonstrated efficacy for adipocytic STS and GIST, but does not make a leiomyosarcoma-only indication. NCI PDQ is an evidence summary, not personalized advice. Confidence/conflicts: High for broad adult STS and FDA pazopanib facts; leiomyosarcoma-specific access remains inferred only as non-adipocytic/non-GIST STS context, not recorded as a subtype-specific FDA claim.
  • Surgery; radiation therapy; chemotherapy including doxorubicin/ifosfamide contexts; pazopanib (Votrient)[8]FDA-approvedNo biomarker required by fetched sources; Localized/resectable STS settings for surgery/radiation/chemotherapy; advanced STS after prior chemotherapy for pazopanib label. · These are adult STS sources rather than leiomyosarcoma-only approvals. Pazopanib label excludes demonstrated efficacy for adipocytic STS and GIST, but does not make a leiomyosarcoma-only indication. NCI PDQ is an evidence summary, not personalized advice. Confidence/conflicts: High for broad adult STS and FDA pazopanib facts; leiomyosarcoma-specific access remains inferred only as non-adipocytic/non-GIST STS context, not recorded as a subtype-specific FDA claim.
  • Surgery; radiation therapy; chemotherapy including doxorubicin/ifosfamide contexts; pazopanib (Votrient)[8]FDA-approvedNo biomarker required by fetched sources; Localized/resectable STS settings for surgery/radiation/chemotherapy; advanced STS after prior chemotherapy for pazopanib label. · These are adult STS sources rather than leiomyosarcoma-only approvals. Pazopanib label excludes demonstrated efficacy for adipocytic STS and GIST, but does not make a leiomyosarcoma-only indication. NCI PDQ is an evidence summary, not personalized advice. Confidence/conflicts: High for broad adult STS and FDA pazopanib facts; leiomyosarcoma-specific access remains inferred only as non-adipocytic/non-GIST STS context, not recorded as a subtype-specific FDA claim.
  • Surgery; radiation therapy; chemotherapy including doxorubicin/ifosfamide contexts; pazopanib (Votrient)[8]FDA-approvedNo biomarker required by fetched sources; Localized/resectable STS settings for surgery/radiation/chemotherapy; advanced STS after prior chemotherapy for pazopanib label. · These are adult STS sources rather than leiomyosarcoma-only approvals. Pazopanib label excludes demonstrated efficacy for adipocytic STS and GIST, but does not make a leiomyosarcoma-only indication. NCI PDQ is an evidence summary, not personalized advice. Confidence/conflicts: High for broad adult STS and FDA pazopanib facts; leiomyosarcoma-specific access remains inferred only as non-adipocytic/non-GIST STS context, not recorded as a subtype-specific FDA claim.
  • Surgery; radiation therapy; chemotherapy including doxorubicin/ifosfamide contexts; pazopanib (Votrient)[8]FDA-approvedNo biomarker required by fetched sources; Localized/resectable STS settings for surgery/radiation/chemotherapy; advanced STS after prior chemotherapy for pazopanib label. · These are adult STS sources rather than leiomyosarcoma-only approvals. Pazopanib label excludes demonstrated efficacy for adipocytic STS and GIST, but does not make a leiomyosarcoma-only indication. NCI PDQ is an evidence summary, not personalized advice. Confidence/conflicts: High for broad adult STS and FDA pazopanib facts; leiomyosarcoma-specific access remains inferred only as non-adipocytic/non-GIST STS context, not recorded as a subtype-specific FDA claim.
  • avapritinib (Ayvakit)[9]FDA-approvedPDGFRA exon 18 mutation, including PDGFRA D842V; unresectable or metastatic GIST with the stated PDGFRA exon 18 mutation. · The FDA label states patient selection is based on presence of a PDGFRA exon 18 mutation and notes that an FDA-approved test for detection of exon 18 mutations was not currently available in that label.
  • entrectinib (Rozlytrek)[10]FDA-approvedNTRK gene fusion; Metastatic or unresectable NTRK fusion-positive sarcoma after standard treatment and with no other effective option; pediatric age scope expanded in 2023. · The fetched source is an NCI government summary of FDA action rather than the FDA approval page itself. The approval is tumor-agnostic, and the source emphasizes prior standard treatment plus no-effective-options criteria. Confidence/conflicts: High for the FDA approval summary and sarcoma-relevant eligibility framing; no conflicting fetched source.
  • imatinib mesylate (Gleevec)[11]FDA-approvedKIT (CD117)-positive; unresectable/metastatic malignant GIST; adjuvant treatment following complete gross resection, as stated in the FDA label. · The label ties these GIST indications to KIT (CD117)-positive disease and states that the optimal duration of adjuvant treatment is not known.
  • larotrectinib (Vitrakvi)[12]FDA-approvedNTRK gene fusion without a known acquired resistance mutation; Metastatic or surgery-morbid NTRK fusion-positive sarcoma in adults or children when no satisfactory alternative exists or after progression following treatment. · The fetched FDA page is the original accelerated-approval notice rather than a current full-label page; continued approval language applied on that notice. The approval is tumor-agnostic, so sarcoma use still depends on confirmed NTRK fusion and clinical fit rather than histology alone. Confidence/conflicts: High for FDA-cleared indication and sarcoma-relevant setting; no conflicting fetched source, with routine accelerated-approval caveat noted. FDA converted larotrectinib (Vitrakvi) from accelerated to FULL/regular tumor-agnostic approval on 10 April 2025 for NTRK gene fusion-positive solid tumors (confirmatory trials LOXO-TRK-14001, SCOUT, NAVIGATE; pooled ORR ~60%). The prior 'FDA accelerated approval'/'restricted' label is stale — upgraded to full approval. Only relevant if the sarcoma carries an NTRK gene fusion (a rare biomarker) confirmed by molecular testing; not a general sarcoma therapy.
  • nab-sirolimus (Fyarro)[13]Approvedno biomarker requirement stated in the fetched label; mTOR-pathway biology is background only; Adult locally advanced unresectable or metastatic malignant PEComa; label gives dosing until disease progression or unacceptable toxicity. · The fetched label is adult-only, does not rank FYARRO against surgery or other systemic options, and includes monitoring and dose-modification cautions for stomatitis, myelosuppression, infection, hyperglycemia/hypokalemia, pneumonitis, hemorrhage, hypersensitivity, and CYP3A4/P-gp interactions. Confidence/conflicts: High for current U.S. label status and setting; no conflicting fetched source.
  • nirogacestat (Ogsiveo)[14]FDA-approvedadult patients with progressing desmoid tumors who require systemic treatment. · FDA approval and label confirm U.S. indication scope only. The label carries substantial safety monitoring language including diarrhea, ovarian toxicity, hepatotoxicity, non-melanoma skin cancers, electrolyte abnormalities, and embryo-fetal toxicity warnings. Confidence/conflicts: high for U.S. indication and safety-monitoring scope; no conflict identified between the approval notice and label.
  • pazopanib (Votrient)[8]FDA-approvedadvanced STS after prior chemotherapy. · The FDA label states that efficacy has not been demonstrated for adipocytic soft tissue sarcoma or gastrointestinal stromal tumors.
  • pexidartinib (Turalio)[15]FDA-approvednot biomarker-specific; adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. · The FDA label carries a boxed hepatotoxicity warning and states Turalio is available only through the TURALIO REMS Program. This is a U.S. label-access finding, not a statement that surgery is inappropriate in any individual case. Confidence/conflicts: high for U.S. indication scope and REMS/hepatotoxicity access caveats; no conflict identified.
  • regorafenib (Stivarga)[16]FDA-approvedlocally advanced, unresectable, or metastatic GIST after prior imatinib mesylate and sunitinib malate. · The fetched FDA label is the 2013 label revision that added the GIST indication and states it may not be the latest approved labeling. It supports the U.S. third-line sequencing concept, but current-label details should be refreshed before patient-facing reuse. Confidence/conflicts: high for the existence and scope of the U.S. post-imatinib/post-sunitinib GIST indication; medium-high for current-label freshness because the fetched PDF notes it may not be the latest approved labeling. No indication conflict identified.
  • repotrectinib (Augtyro)[17]FDA accelerated approvalNTRK gene fusion; Adult and pediatric age 12+ locally advanced, metastatic, or surgery-morbid NTRK fusion-positive sarcoma after progression or where no satisfactory alternative therapy exists. · This is an accelerated approval. The pivotal trial included both TRK-inhibitor-naive and TRK-pretreated cohorts, so the source supports use across both contexts when the label criteria are met, but it does not rank repotrectinib against other TRK inhibitors for a given sarcoma. Confidence/conflicts: High for FDA-cleared indication and post-progression/no-alternative setting; no conflicting fetched source.
  • ripretinib (Qinlock)[18]FDA-approvednot biomarker-gated in the fetched label beyond diagnosis of GIST; advanced GIST after 3 or more prior kinase inhibitors including imatinib. · The label specifies prior treatment with 3 or more kinase inhibitors, including imatinib; it does not frame this as an earlier-line option.
  • sunitinib malate (Sutent)[19]FDA-approvedafter disease progression on or intolerance to imatinib mesylate. · The fetched FDA label is the original 2006 label and explicitly says it may not be the latest approved labeling. It still supports the U.S. indication framework for the post-imatinib GIST setting, but current formulation/generic-label updates should be checked before patient-facing reuse. Confidence/conflicts: high for the existence and scope of the U.S. post-imatinib GIST indication; medium-high for current-label freshness because the fetched PDF is an older FDA label that notes it may not be the latest approved labeling. No indication conflict identified.
  • trabectedin (Yondelis)[20]FDA-approvedunresectable or metastatic liposarcoma or leiomyosarcoma after prior anthracycline-containing treatment. · The label is subtype-specific to liposarcoma or leiomyosarcoma and requires prior anthracycline-containing treatment.

European Union

  • Eribulin (Halaven); trabectedin (Yondelis)[21]EMA authorisedNo biomarker required by fetched EMA sources; Unresectable/metastatic liposarcoma after anthracycline-containing regimen for eribulin; advanced STS after anthracycline/ifosfamide failure or unsuitability for trabectedin. · EMA central authorization does not establish member-state reimbursement or access. The Halaven exact indication should be refreshed from EMA product information before patient-facing quoting. Confidence/conflicts: Medium-high; trabectedin details directly fetched from EMA page, Halaven exact indication needs product-information refresh.
  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy[22]EMA authorisedNo biomarker required by fetched EMA source; Postoperative treatment after macroscopically complete resection of high-grade resectable non-metastatic osteosarcoma in children, adolescents, and young adults. · EMA central authorization does not establish member-state reimbursement or local availability. Age range, surgical completeness, metastatic status, and chemotherapy plan are key source-stated conditions. Confidence/conflicts: High for EMA indication and age/stage/surgery constraints; member-state access unverified.
  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy[22]EMA authorisedNo biomarker required by fetched EMA source; Postoperative treatment after macroscopically complete resection of high-grade resectable non-metastatic osteosarcoma in children, adolescents, and young adults. · EMA central authorization does not establish member-state reimbursement or local availability. Age range, surgical completeness, metastatic status, and chemotherapy plan are key source-stated conditions. Confidence/conflicts: High for EMA indication and age/stage/surgery constraints; member-state access unverified.
  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy[22]EMA authorisedNo biomarker required by fetched EMA source; Postoperative treatment after macroscopically complete resection of high-grade resectable non-metastatic osteosarcoma in children, adolescents, and young adults. · EMA central authorization does not establish member-state reimbursement or local availability. Age range, surgical completeness, metastatic status, and chemotherapy plan are key source-stated conditions. Confidence/conflicts: High for EMA indication and age/stage/surgery constraints; member-state access unverified.
  • Nirogacestat hydrobromide (Ogsiveo)[23]EMA authorisedNo biomarker required by fetched EMA EPAR; Adult progressing desmoid tumours requiring systemic treatment. · EMA central authorisation does not establish Germany/France reimbursement timing, local prescribing restrictions, or individual eligibility. EMA notes additional monitoring status. Confidence/conflicts: High for EU central authorisation; reimbursement/access remains member-state specific.
  • Pazopanib (Votrient); trabectedin (Yondelis) broad STS context[24]EMA authorisedNo synovial sarcoma-specific biomarker requirement in fetched EMA broad STS sources; Broad advanced STS settings only; not recorded as synovial-sarcoma-specific approval. · This cell is broad STS EU context, not a synovial-specific EU approval. Member-state reimbursement and any EU TCR/cell-therapy authorization require separate verification. Confidence/conflicts: Medium for synovial sarcoma because sources are broad STS; explicit EU Tecelra-equivalent source not verified.
  • Pazopanib (Votrient); trabectedin (Yondelis) broad STS context[24]EMA authorisedNo synovial sarcoma-specific biomarker requirement in fetched EMA broad STS sources; Broad advanced STS settings only; not recorded as synovial-sarcoma-specific approval. · This cell is broad STS EU context, not a synovial-specific EU approval. Member-state reimbursement and any EU TCR/cell-therapy authorization require separate verification. Confidence/conflicts: Medium for synovial sarcoma because sources are broad STS; explicit EU Tecelra-equivalent source not verified.
  • Trabectedin (Yondelis); pazopanib (Votrient)[25]EMA authorisedNo biomarker required by fetched EMA sources; Advanced soft-tissue sarcoma after anthracycline/ifosfamide failure or unsuitability for trabectedin; advanced STS label context for pazopanib pending product-information refresh. · EMA central authorization does not establish member-state reimbursement or local access. Votrient indication detail should be refreshed from product information before surfacing as leiomyosarcoma-specific. Confidence/conflicts: High for trabectedin EU facts; medium for pazopanib EU STS detail pending product-information text refresh.
  • Trabectedin (Yondelis); pazopanib (Votrient)[25]EMA authorisedNo biomarker required by fetched EMA sources; Advanced soft-tissue sarcoma after anthracycline/ifosfamide failure or unsuitability for trabectedin; advanced STS label context for pazopanib pending product-information refresh. · EMA central authorization does not establish member-state reimbursement or local access. Votrient indication detail should be refreshed from product information before surfacing as leiomyosarcoma-specific. Confidence/conflicts: High for trabectedin EU facts; medium for pazopanib EU STS detail pending product-information text refresh.
  • avapritinib (Ayvakyt)[26]EMA authorisedPDGFRA D842V mutation; unresectable metastatic GIST with PDGFRA D842V mutation. · The fetched EMA page is mutation-specific and disease-setting-specific; it does not support use for all GIST or for non-metastatic resectable disease. EMA notes this is a conditional marketing authorisation. Confidence/conflicts: high for EMA mutation-specific GIST indication; no conflict identified. Member-state reimbursement remains unverified.
  • imatinib (Glivec)[27]EMA authorisednot biomarker-specified on the fetched EMA summary page; unresectable or metastatic GIST; adjuvant context after surgical removal in adults at risk of recurrence. · The fetched EMA summary page does not add the KIT (CD117)-positive qualifier used in some other jurisdictions, and it frames adjuvant use around adults at risk of recurrence after surgery rather than a fixed-duration requirement. Confidence/conflicts: high for EMA central-authorisation scope on unresectable/metastatic and postoperative-risk contexts; no conflict identified. Member-state reimbursement remains unverified.
  • regorafenib (Stivarga)[28]EMA authorisednot biomarker-specified on the fetched EMA summary page; unresectable or metastatic GIST after prior imatinib and sunitinib. · The EMA summary page supports a post-imatinib/post-sunitinib sequencing concept but does not provide mutation-specific selection criteria in the displayed lines. Confidence/conflicts: high for EMA post-imatinib/post-sunitinib GIST indication scope; no conflict identified. Member-state reimbursement remains unverified.
  • ripretinib (Qinlock)[29]EMA authorisednot biomarker-specified on the fetched EMA summary page beyond GIST biology involving KIT and PDGFRA; advanced GIST after three or more prior kinase inhibitors including imatinib. · The indication is late-line and does not establish earlier-line use. The fetched EMA page frames the disease as advanced and previously treated with three or more kinase inhibitors. Confidence/conflicts: high for EMA late-line advanced GIST indication; no conflict identified. Member-state reimbursement remains unverified.
  • sunitinib (Sutent)[30]EMA authorisednot biomarker-specified on the fetched EMA summary page; unresectable or metastatic GIST after imatinib treatment failure. · The fetched EMA summary page does not distinguish failure because of progression versus intolerance in the displayed lines, and it is not a first-line GIST source. Confidence/conflicts: high for EMA sequencing after imatinib failure; no conflict identified. Member-state reimbursement remains unverified.

United Kingdom

  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy; surgery and chemotherapy within UK bone sarcoma guideline context[31]NICE recommendedNo biomarker required by fetched UK sources; Post-surgery non-metastatic high-grade osteosarcoma age 2 to 30 years for mifamurtide/NICE context; bone sarcoma specialist management pathway. · NICE applies to England unless otherwise stated; exact recommendation details should be checked in TA235 before patient-facing quoting. Devolved nations, funding route, and local bone sarcoma MDT decisions remain separate. Confidence/conflicts: Medium-high; NICE overview verified but exact recommendation chapter still needs refresh for integration.
  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy; surgery and chemotherapy within UK bone sarcoma guideline context[31]NICE recommendedNo biomarker required by fetched UK sources; Post-surgery non-metastatic high-grade osteosarcoma age 2 to 30 years for mifamurtide/NICE context; bone sarcoma specialist management pathway. · NICE applies to England unless otherwise stated; exact recommendation details should be checked in TA235 before patient-facing quoting. Devolved nations, funding route, and local bone sarcoma MDT decisions remain separate. Confidence/conflicts: Medium-high; NICE overview verified but exact recommendation chapter still needs refresh for integration.
  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy; surgery and chemotherapy within UK bone sarcoma guideline context[31]NICE recommendedNo biomarker required by fetched UK sources; Post-surgery non-metastatic high-grade osteosarcoma age 2 to 30 years for mifamurtide/NICE context; bone sarcoma specialist management pathway. · NICE applies to England unless otherwise stated; exact recommendation details should be checked in TA235 before patient-facing quoting. Devolved nations, funding route, and local bone sarcoma MDT decisions remain separate. Confidence/conflicts: Medium-high; NICE overview verified but exact recommendation chapter still needs refresh for integration.
  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy; surgery and chemotherapy within UK bone sarcoma guideline context[31]NICE recommendedNo biomarker required by fetched UK sources; Post-surgery non-metastatic high-grade osteosarcoma age 2 to 30 years for mifamurtide/NICE context; bone sarcoma specialist management pathway. · NICE applies to England unless otherwise stated; exact recommendation details should be checked in TA235 before patient-facing quoting. Devolved nations, funding route, and local bone sarcoma MDT decisions remain separate. Confidence/conflicts: Medium-high; NICE overview verified but exact recommendation chapter still needs refresh for integration.
  • Nirogacestat hydrobromide (Ogsiveo)[32]ApprovedNo biomarker required by fetched MHRA/NICE sources; Adults with progressing desmoid tumours; NICE reimbursement/appraisal pathway still pending as of fetched source. · MHRA approval is regulatory and does not by itself establish NHS commissioning or NICE recommendation. NICE appraisal is in progress and should be rechecked after the expected publication date. Confidence/conflicts: High for MHRA approval; NHS access confidence limited because NICE appraisal remains in progress.
  • Regorafenib (Stivarga); ripretinib (Qinlock)[33]ApprovedNo mutation biomarker required by NICE regorafenib/ripretinib recommendation text; prior kinase inhibitor sequence is central; Regorafenib after imatinib and sunitinib; ripretinib after 3 or more kinase inhibitors including imatinib. · NICE recommendations apply to England unless otherwise stated and include commercial/patient-access arrangements. Scotland, Wales, Northern Ireland, and MHRA label detail remain separate cells. Confidence/conflicts: High for NICE England-context recommendations; no conflict identified.
  • Regorafenib (Stivarga); ripretinib (Qinlock)[33]ApprovedNo mutation biomarker required by NICE regorafenib/ripretinib recommendation text; prior kinase inhibitor sequence is central; Regorafenib after imatinib and sunitinib; ripretinib after 3 or more kinase inhibitors including imatinib. · NICE recommendations apply to England unless otherwise stated and include commercial/patient-access arrangements. Scotland, Wales, Northern Ireland, and MHRA label detail remain separate cells. Confidence/conflicts: High for NICE England-context recommendations; no conflict identified.
  • Trabectedin (Yondelis); surgery, radiotherapy, systemic anticancer therapy categories in UK STS guideline context[34]NICE recommendedNo biomarker required by fetched sources; Advanced STS after anthracycline/ifosfamide failure or unsuitability for trabectedin; broader UK STS specialist management context. · NICE applies to England unless otherwise stated and does not establish devolved nation policy. UK STS guideline is broad STS guidance, not a leiomyosarcoma-only reimbursement decision. Confidence/conflicts: High for NICE trabectedin recommendation; broad STS guideline context is not subtype-specific reimbursement.
  • Trabectedin (Yondelis); surgery, radiotherapy, systemic anticancer therapy categories in UK STS guideline context[34]NICE recommendedNo biomarker required by fetched sources; Advanced STS after anthracycline/ifosfamide failure or unsuitability for trabectedin; broader UK STS specialist management context. · NICE applies to England unless otherwise stated and does not establish devolved nation policy. UK STS guideline is broad STS guidance, not a leiomyosarcoma-only reimbursement decision. Confidence/conflicts: High for NICE trabectedin recommendation; broad STS guideline context is not subtype-specific reimbursement.
  • Trabectedin (Yondelis); surgery, radiotherapy, systemic anticancer therapy categories in UK STS guideline context[34]NICE recommendedNo biomarker required by fetched sources; Advanced STS after anthracycline/ifosfamide failure or unsuitability for trabectedin; broader UK STS specialist management context. · NICE applies to England unless otherwise stated and does not establish devolved nation policy. UK STS guideline is broad STS guidance, not a leiomyosarcoma-only reimbursement decision. Confidence/conflicts: High for NICE trabectedin recommendation; broad STS guideline context is not subtype-specific reimbursement.
  • Trabectedin (Yondelis); surgery, radiotherapy, systemic anticancer therapy categories in UK STS guideline context[34]NICE recommendedNo biomarker required by fetched sources; Advanced STS after anthracycline/ifosfamide failure or unsuitability for trabectedin; broader UK STS specialist management context. · NICE applies to England unless otherwise stated and does not establish devolved nation policy. UK STS guideline is broad STS guidance, not a leiomyosarcoma-only reimbursement decision. Confidence/conflicts: High for NICE trabectedin recommendation; broad STS guideline context is not subtype-specific reimbursement.

출처

  1. Desmoid Tumor Research Foundation (DTRF) — patient-advocacy guideline-context information · patient-advocacy guideline-context information
  2. U.S. Food and Drug Administration (FDA) — regulator accelerated approval notice · regulator accelerated approval notice
  3. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  4. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  5. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  6. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  7. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  8. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  9. U.S. Food and Drug Administration — official drug label · official drug label
  10. National Cancer Institute — national cancer agency FDA approval summary · national cancer agency FDA approval summary
  11. U.S. Food and Drug Administration — official drug label · official drug label
  12. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  13. DailyMed / National Library of Medicine — official drug label · official drug label
  14. U.S. Food and Drug Administration — official drug label · official drug label
  15. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  16. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  17. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  18. U.S. Food and Drug Administration — official drug label · official drug label
  19. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  20. U.S. Food and Drug Administration — official drug label · official drug label
  21. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  22. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  23. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  24. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  25. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  26. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  27. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  28. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  29. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  30. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  31. NICE — technology appraisal guidance overview · technology appraisal guidance overview
  32. Medicines and Healthcare products Regulatory Agency (MHRA) / GOV.UK — regulator approval press release · regulator approval press release
  33. NICE — technology appraisal guidance · technology appraisal guidance
  34. NICE — technology appraisal guidance · technology appraisal guidance

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