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Uveal melanoma: 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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임상시험 검색어

Uveal melanoma 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

  • Melphalan for injection / Hepatic Delivery System (HEPZATO KIT; HEPZATO melphalan)[1]FDA-approvedNo HLA genotype requirement stated in the FDA/DailyMed indication; liver-metastasis distribution criteria are central to the label.; Adult uveal melanoma with unresectable hepatic metastases in the labeled liver-dominant context; FDA notes the FOCUS study included patients with unresectable hepatic metastases and limited extrahepatic disease if the life-threatening component was in the liver and extrahepatic sites had a defined treatment plan. · DailyMed and FDA describe boxed warnings for severe peri-procedural complications and myelosuppression; DailyMed states HEPZATO KIT is available only through a restricted REMS program and should be used by trained healthcare providers. The label includes contraindications and procedural restrictions; this entry does not imply an individual patient meets them. Confidence/conflicts: High; FDA approval notice and current DailyMed label align on the core U.S. indication. No conflict found.
  • Melphalan for injection / Hepatic Delivery System (HEPZATO KIT; HEPZATO melphalan)[1]FDA-approvedNo HLA genotype requirement stated in the FDA/DailyMed indication; liver-metastasis distribution criteria are central to the label.; Adult uveal melanoma with unresectable hepatic metastases in the labeled liver-dominant context; FDA notes the FOCUS study included patients with unresectable hepatic metastases and limited extrahepatic disease if the life-threatening component was in the liver and extrahepatic sites had a defined treatment plan. · DailyMed and FDA describe boxed warnings for severe peri-procedural complications and myelosuppression; DailyMed states HEPZATO KIT is available only through a restricted REMS program and should be used by trained healthcare providers. The label includes contraindications and procedural restrictions; this entry does not imply an individual patient meets them. Confidence/conflicts: High; FDA approval notice and current DailyMed label align on the core U.S. indication. No conflict found.
  • Melphalan for injection / Hepatic Delivery System (HEPZATO KIT; HEPZATO melphalan)[1]FDA-approvedNo HLA genotype requirement stated in the FDA/DailyMed indication; liver-metastasis distribution criteria are central to the label.; Adult uveal melanoma with unresectable hepatic metastases in the labeled liver-dominant context; FDA notes the FOCUS study included patients with unresectable hepatic metastases and limited extrahepatic disease if the life-threatening component was in the liver and extrahepatic sites had a defined treatment plan. · DailyMed and FDA describe boxed warnings for severe peri-procedural complications and myelosuppression; DailyMed states HEPZATO KIT is available only through a restricted REMS program and should be used by trained healthcare providers. The label includes contraindications and procedural restrictions; this entry does not imply an individual patient meets them. Confidence/conflicts: High; FDA approval notice and current DailyMed label align on the core U.S. indication. No conflict found.
  • radiation therapy, including plaque radiation therapy and external-beam charged-particle radiation therapy as described by NCI PDQ[2]NCI PDQ: standard optionlocal treatment for intraocular/uveal melanoma, including medium and large choroidal melanoma settings. · NCI PDQ notes charged-particle radiation is offered at specialized referral centers and requires careful patient cooperation. It also distinguishes radiation options by tumor extent and clinical factors.
  • surgery, including resection and enucleation as described by NCI PDQ[2]NCI PDQ: standard optionprimary intraocular/uveal melanoma local treatment; medium/large choroidal melanoma context depends on tumor size and extent. · NCI PDQ is an information summary, not a patient-specific eligibility rule. The source emphasizes treatment depends on tumor factors and clinical context.
  • tebentafusp-tebn (Kimmtrak)[3]FDA-approvedHLA-A*02:01-positive; unresectable or metastatic uveal melanoma; FDA approval notice describes IMCgp100-202 in metastatic uveal melanoma and notes patients were required to be HLA-A*02:01 genotype positive. · FDA label states patient selection is based on positive HLA-A*02:01 genotyping and that an FDA-approved test for HLA-A*02:01 genotyping was not currently available in the 2022 label. The label includes a boxed warning for cytokine release syndrome and monitoring requirements.

European Union

  • tebentafusp (Kimmtrak)[4]EMA authorisedHLA-A*02:01-positive implied by Kimmtrak product context; EMA overview states uveal melanoma cannot be removed by surgery or has spread; unresectable or metastatic uveal melanoma. · EMA states Kimmtrak should be given under supervision of a doctor experienced with cancer medicines and cytokine release syndrome, and in a setting where CRS can be managed. Member-state reimbursement, including Germany/France, was not verified in this cell. Confidence/conflicts: high for EMA-authorised status; no source conflict identified. Member-state reimbursement unverified.
  • tebentafusp (Kimmtrak)[5]ApprovedHLA-A*02:01-positive; Monotherapy for adult HLA-A*02:01-positive unresectable or metastatic uveal melanoma. · HAS notes important monitoring issues including acute skin reactions, cardiac disorders, and cytokine release syndrome in the source summary. This entry does not establish individual eligibility or availability at a specific French center. Confidence/conflicts: High for France HAS reimbursement and population scope. No conflict identified.
  • tebentafusp (Kimmtrak)[6]ApprovedHLA-A*02:01-positive; Monotherapy for adult HLA-A*02:01-positive unresectable/inoperable or metastatic uveal melanoma in the German G-BA benefit-assessment context. · Source is in German; human-language review is needed before patient-facing reuse. The entry records G-BA assessment/indication context and does not capture current negotiated price or center-level access. Confidence/conflicts: Medium-high for Germany G-BA indication/assessment context; language review required and current access implementation not captured. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.

United Kingdom

  • tebentafusp (Kimmtrak)[7]ApprovedHLA-A*02:01-positive; HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults. · NICE states there is no standard treatment specifically for this population and that tebentafusp is recommended under the commercial arrangement. The recommendation is an NHS access appraisal, not a universal UK/private-sector availability statement.
  • tebentafusp (Kimmtrak)[8]ApprovedHLA-A*02:01-positive; Adult HLA-A*02:01-positive unresectable or metastatic uveal melanoma. · The SmPC establishes the UK product-information indication, not devolved NHS reimbursement. The SmPC flags administration under experienced supervision and cytokine release syndrome preparedness. Confidence/conflicts: High for UK SmPC indication. Devolved access differs by jurisdiction and is recorded separately below.
  • tebentafusp (Kimmtrak)[9]ApprovedHLA-A*02:01-positive; NICE technology-appraisal recommendation for adults with HLA-A*02:01-positive unresectable or metastatic uveal melanoma; used primarily as first-line treatment in committee discussion. · NICE recommendations apply to NHS commissioning contexts covered by NICE implementation rules and include a confidential commercial arrangement. They should not be generalized to Scotland without SMC verification. Confidence/conflicts: High for NICE recommendation and conditions. Conflicts with Scotland SMC non-recommendation are recorded in Finding BKJ-3.
  • tebentafusp (Kimmtrak)[9]ApprovedHLA-A*02:01-positive; NICE technology-appraisal recommendation for adults with HLA-A*02:01-positive unresectable or metastatic uveal melanoma; used primarily as first-line treatment in committee discussion. · NICE recommendations apply to NHS commissioning contexts covered by NICE implementation rules and include a confidential commercial arrangement. They should not be generalized to Scotland without SMC verification. Confidence/conflicts: High for NICE recommendation and conditions. Conflicts with Scotland SMC non-recommendation are recorded in Finding BKJ-3.
  • tebentafusp (Kimmtrak)[10]ApprovedHLA-A*02:01-positive; NHSScotland routine-use appraisal for adult HLA-A*02:01-positive unresectable or metastatic uveal melanoma. · This is a non-recommendation for routine NHSScotland use, not a statement that the drug lacks UK marketing authorization. SMC public summary says an individual request may still be considered by health boards if a clinician thinks a patient may benefit. Confidence/conflicts: High for Scotland SMC non-recommendation. Conflict/divergence noted with NICE recommendation for England/Wales contexts.
  • tebentafusp (Kimmtrak)[10]ApprovedHLA-A*02:01-positive; NHSScotland routine-use appraisal for adult HLA-A*02:01-positive unresectable or metastatic uveal melanoma. · This is a non-recommendation for routine NHSScotland use, not a statement that the drug lacks UK marketing authorization. SMC public summary says an individual request may still be considered by health boards if a clinician thinks a patient may benefit. Confidence/conflicts: High for Scotland SMC non-recommendation. Conflict/divergence noted with NICE recommendation for England/Wales contexts.

Australia

  • tebentafusp (Kimmtrak)[11]TGA-registered (Australia)HLA-A*02:01-positive; Adult HLA-A*02:01-positive unresectable or metastatic uveal melanoma. · TGA approval does not alone establish PBS subsidy, treatment-center availability, or individual eligibility. Biomarker confirmation and specialist oversight are central to the indication. Confidence/conflicts: High for Australian regulatory approval and indication. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • tebentafusp (Kimmtrak)[12]ApprovedHLA-A*02:01-positive; eviQ protocol indicates adult HLA-A*02:01-positive population and ECOG 0 to 1; PBS/eviQ access and protocol context for advanced unresectable or metastatic HLA-A*02:01-positive uveal melanoma. · PBS authority and eviQ protocol context do not establish individual PBS authority approval, inpatient billing details, or local hospital capacity. eviQ flags cytokine release syndrome monitoring and appropriate setting requirements. Confidence/conflicts: High for PBS listing status and eviQ protocol context. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • tebentafusp (Kimmtrak)[12]ApprovedHLA-A*02:01-positive; eviQ protocol indicates adult HLA-A*02:01-positive population and ECOG 0 to 1; PBS/eviQ access and protocol context for advanced unresectable or metastatic HLA-A*02:01-positive uveal melanoma. · PBS authority and eviQ protocol context do not establish individual PBS authority approval, inpatient billing details, or local hospital capacity. eviQ flags cytokine release syndrome monitoring and appropriate setting requirements. Confidence/conflicts: High for PBS listing status and eviQ protocol context. No conflict identified. Availability/reimbursement outside the approving regulator not established.

Canada

  • tebentafusp (Kimmtrak)[13]Health Canada approvedHLA-A*02:01-positive; Adult HLA-A*02:01-positive unresectable or metastatic uveal melanoma. · Health Canada authorization does not by itself establish public-drug-plan reimbursement or site availability. The SBD records monitoring and safety issues through the product monograph context. Confidence/conflicts: High for Canadian authorization and adult indication scope. No conflict identified.
  • tebentafusp (Kimmtrak)[14]ApprovedHLA-A*02:01-positive; clinically stable CNS disease or no brain metastases in CADTH conditions; First-line public-payer reimbursement recommendation for adult HLA-A*02:01-positive unresectable or metastatic uveal melanoma, with CADTH conditions. · CADTH recommendations guide Canadian public drug plans but do not prove every province or territory has implemented identical criteria. Local formulary confirmation remains needed. Confidence/conflicts: High for CADTH reimbursement conditions; province-by-province implementation remains a gap. No conflict identified.
  • tebentafusp (Kimmtrak)[14]ApprovedHLA-A*02:01-positive; clinically stable CNS disease or no brain metastases in CADTH conditions; First-line public-payer reimbursement recommendation for adult HLA-A*02:01-positive unresectable or metastatic uveal melanoma, with CADTH conditions. · CADTH recommendations guide Canadian public drug plans but do not prove every province or territory has implemented identical criteria. Local formulary confirmation remains needed. Confidence/conflicts: High for CADTH reimbursement conditions; province-by-province implementation remains a gap. No conflict identified.

출처

  1. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  2. National Cancer Institute — national cancer agency PDQ · national cancer agency PDQ
  3. U.S. Food and Drug Administration — official drug label · official drug label
  4. European Medicines Agency — regulator product page / EPAR · regulator product page / EPAR
  5. Haute Autorite de Sante (HAS) — HTA reimbursement opinion English summary · HTA reimbursement opinion English summary
  6. Gemeinsamer Bundesausschuss (G-BA) — AMNOG benefit-assessment procedure page · AMNOG benefit-assessment procedure page
  7. National Institute for Health and Care Excellence (NICE) — health technology appraisal / guideline · health technology appraisal / guideline
  8. electronic Medicines Compendium (emc) / Immunocore — UK Summary of Product Characteristics · UK Summary of Product Characteristics
  9. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  10. Scottish Medicines Consortium (SMC) — medicine advice · medicine advice
  11. Therapeutic Goods Administration (TGA) — Australian Prescription Medicine Decision Summary · Australian Prescription Medicine Decision Summary
  12. Australian Pharmaceutical Benefits Scheme (PBS) Medicine Status Website — PBS medicine status / listing record · PBS medicine status / listing record
  13. Health Canada Drug and Health Products Portal — Summary Basis of Decision · Summary Basis of Decision
  14. NCBI Bookshelf / CADTH — reimbursement recommendation table · reimbursement recommendation table

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. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.