선택지 정리됨
Mesothelioma: 국가별 선택지
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선택지 정리됨고형암최종 확인 2026.06
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임상시험 검색어
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
- Pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy[1]FDA-approvedNo biomarker requirement stated in fetched FDA approval notice; First-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma; KEYNOTE-483 enrolled patients with no prior systemic therapy for advanced/metastatic disease. · FDA approval notice does not establish payer coverage, individual eligibility, or choice versus other first-line options. Confidence/conflicts: High for U.S. approval; no superiority claim over other first-line regimens.
- Pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy[1]FDA-approvedNo biomarker requirement stated in fetched FDA approval notice; First-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma; KEYNOTE-483 enrolled patients with no prior systemic therapy for advanced/metastatic disease. · FDA approval notice does not establish payer coverage, individual eligibility, or choice versus other first-line options. Confidence/conflicts: High for U.S. approval; no superiority claim over other first-line regimens.
- Pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy[1]FDA-approvedNo biomarker requirement stated in fetched FDA approval notice; First-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma; KEYNOTE-483 enrolled patients with no prior systemic therapy for advanced/metastatic disease. · FDA approval notice does not establish payer coverage, individual eligibility, or choice versus other first-line options. Confidence/conflicts: High for U.S. approval; no superiority claim over other first-line regimens.
European Union
- Ipilimumab (Yervoy) with nivolumab (Opdivo); pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy[2]EMA authorisedNo biomarker requirement stated in fetched EMA product pages for the MPM indications; First-line adult unresectable MPM; Keytruda indication specifically non-epithelioid MPM per fetched EMA source. · EMA central authorization does not establish Germany/France reimbursement timing or local prescribing restrictions. Histology matters for the fetched Keytruda EU indication. Confidence/conflicts: High for EU indication text; member-state access remains to verify.
- Ipilimumab (Yervoy) with nivolumab (Opdivo); pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy[2]EMA authorisedNo biomarker requirement stated in fetched EMA product pages for the MPM indications; First-line adult unresectable MPM; Keytruda indication specifically non-epithelioid MPM per fetched EMA source. · EMA central authorization does not establish Germany/France reimbursement timing or local prescribing restrictions. Histology matters for the fetched Keytruda EU indication. Confidence/conflicts: High for EU indication text; member-state access remains to verify.
- Ipilimumab (Yervoy) with nivolumab (Opdivo); pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy[2]EMA authorisedNo biomarker requirement stated in fetched EMA product pages for the MPM indications; First-line adult unresectable MPM; Keytruda indication specifically non-epithelioid MPM per fetched EMA source. · EMA central authorization does not establish Germany/France reimbursement timing or local prescribing restrictions. Histology matters for the fetched Keytruda EU indication. Confidence/conflicts: High for EU indication text; member-state access remains to verify.
United Kingdom
- Nivolumab (Opdivo) with ipilimumab (Yervoy)[3]ApprovedNo biomarker requirement stated in fetched NICE TA818 recommendation; Untreated unresectable malignant pleural mesothelioma in adults. · NICE recommendation is conditional on ECOG performance status and commercial arrangement. Devolved nation implementation and local pathway details may vary. Confidence/conflicts: High for NICE recommendation in specified population; local implementation still needs care-team confirmation.
- Nivolumab (Opdivo) with ipilimumab (Yervoy)[3]ApprovedNo biomarker requirement stated in fetched NICE TA818 recommendation; Untreated unresectable malignant pleural mesothelioma in adults. · NICE recommendation is conditional on ECOG performance status and commercial arrangement. Devolved nation implementation and local pathway details may vary. Confidence/conflicts: High for NICE recommendation in specified population; local implementation still needs care-team confirmation.
- Pembrolizumab (Keytruda) with pemetrexed and platinum-based chemotherapy[4]ApprovedNo biomarker requirement stated in fetched NICE TA1125 source; Untreated unresectable advanced malignant pleural mesothelioma in adults. · This is not a positive NICE recommendation. It does not establish routine NHS funding; local decision-making may apply if organisations consider the regimen. Confidence/conflicts: High for no NICE recommendation; conflict with U.S. FDA and EU EMA approvals is jurisdiction/access-specific.
- Pembrolizumab (Keytruda) with pemetrexed and platinum-based chemotherapy[4]ApprovedNo biomarker requirement stated in fetched NICE TA1125 source; Untreated unresectable advanced malignant pleural mesothelioma in adults. · This is not a positive NICE recommendation. It does not establish routine NHS funding; local decision-making may apply if organisations consider the regimen. Confidence/conflicts: High for no NICE recommendation; conflict with U.S. FDA and EU EMA approvals is jurisdiction/access-specific.
출처
- U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
- European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
- NICE — technology appraisal recommendation · technology appraisal recommendation
- NICE — terminated technology appraisal advice · terminated technology appraisal advice
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.