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선택지 정리됨

Non-melanoma skin cancer (BCC / cSCC): 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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임상시험 검색어

Non-melanoma skin cancer (BCC / cSCC) 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

  • Surgery; radiation therapy; vismodegib (Erivedge); sonidegib (Odomzo); cemiplimab-rwlc (Libtayo)[1]FDA-approvedHedgehog pathway inhibition treatment context; no mutation biomarker required by fetched sources; Locally advanced or metastatic BCC; advanced BCC where surgery/radiation may not be appropriate; BCC after hedgehog pathway inhibitor treatment or when HHI is not appropriate. · NCI PDQ is an evidence summary, not a payer source. FDA approval notice does not determine individual eligibility, sequencing, tolerability, or reimbursement. Sonidegib and vismodegib indications differ and require label-level confirmation for exact use. Confidence/conflicts: High for U.S. framework and FDA cemiplimab approval; exact HHI label wording and payer access remain follow-up gaps.
  • Surgery; radiation therapy; vismodegib (Erivedge); sonidegib (Odomzo); cemiplimab-rwlc (Libtayo)[1]FDA-approvedHedgehog pathway inhibition treatment context; no mutation biomarker required by fetched sources; Locally advanced or metastatic BCC; advanced BCC where surgery/radiation may not be appropriate; BCC after hedgehog pathway inhibitor treatment or when HHI is not appropriate. · NCI PDQ is an evidence summary, not a payer source. FDA approval notice does not determine individual eligibility, sequencing, tolerability, or reimbursement. Sonidegib and vismodegib indications differ and require label-level confirmation for exact use. Confidence/conflicts: High for U.S. framework and FDA cemiplimab approval; exact HHI label wording and payer access remain follow-up gaps.
  • Surgery; radiation therapy; vismodegib (Erivedge); sonidegib (Odomzo); cemiplimab-rwlc (Libtayo)[1]FDA-approvedHedgehog pathway inhibition treatment context; no mutation biomarker required by fetched sources; Locally advanced or metastatic BCC; advanced BCC where surgery/radiation may not be appropriate; BCC after hedgehog pathway inhibitor treatment or when HHI is not appropriate. · NCI PDQ is an evidence summary, not a payer source. FDA approval notice does not determine individual eligibility, sequencing, tolerability, or reimbursement. Sonidegib and vismodegib indications differ and require label-level confirmation for exact use. Confidence/conflicts: High for U.S. framework and FDA cemiplimab approval; exact HHI label wording and payer access remain follow-up gaps.
  • Surgery; radiation therapy; vismodegib (Erivedge); sonidegib (Odomzo); cemiplimab-rwlc (Libtayo)[1]FDA-approvedHedgehog pathway inhibition treatment context; no mutation biomarker required by fetched sources; Locally advanced or metastatic BCC; advanced BCC where surgery/radiation may not be appropriate; BCC after hedgehog pathway inhibitor treatment or when HHI is not appropriate. · NCI PDQ is an evidence summary, not a payer source. FDA approval notice does not determine individual eligibility, sequencing, tolerability, or reimbursement. Sonidegib and vismodegib indications differ and require label-level confirmation for exact use. Confidence/conflicts: High for U.S. framework and FDA cemiplimab approval; exact HHI label wording and payer access remain follow-up gaps.

European Union

  • Cemiplimab (Libtayo)[2]EMA authorisedNo biomarker requirement stated in fetched EMA page; Adult metastatic or locally advanced cSCC not candidates for curative surgery/radiation; adult high-risk recurrence after surgery and radiation adjuvant setting. · EMA central authorization does not establish reimbursement or access in Germany, France, or other member states. No claim is made for pembrolizumab EU cSCC status from fetched sources. Confidence/conflicts: High for EMA authorization text; member-state reimbursement remains a gap.
  • Cemiplimab (Libtayo)[2]EMA authorisedNo biomarker requirement stated in fetched EMA page; Adult metastatic or locally advanced cSCC not candidates for curative surgery/radiation; adult high-risk recurrence after surgery and radiation adjuvant setting. · EMA central authorization does not establish reimbursement or access in Germany, France, or other member states. No claim is made for pembrolizumab EU cSCC status from fetched sources. Confidence/conflicts: High for EMA authorization text; member-state reimbursement remains a gap.

United Kingdom

  • Cemiplimab (Libtayo)[3]ApprovedNo biomarker requirement stated in fetched NICE recommendation; Adults with metastatic or locally advanced cSCC when curative surgery or curative radiotherapy is not suitable. · NICE recommendation is England/Wales NHS appraisal context and includes stopping and commercial-arrangement conditions. It does not establish Scotland/Northern Ireland status or MHRA label specifics. Confidence/conflicts: High for NICE recommendation text; devolved UK status and MHRA label specifics remain gaps.
  • Cemiplimab (Libtayo)[3]ApprovedNo biomarker requirement stated in fetched NICE recommendation; Adults with metastatic or locally advanced cSCC when curative surgery or curative radiotherapy is not suitable. · NICE recommendation is England/Wales NHS appraisal context and includes stopping and commercial-arrangement conditions. It does not establish Scotland/Northern Ireland status or MHRA label specifics. Confidence/conflicts: High for NICE recommendation text; devolved UK status and MHRA label specifics remain gaps.
  • Vismodegib (Erivedge); best supportive care comparator context[4]ApprovedNo biomarker requirement stated in fetched NICE recommendation; Symptomatic metastatic BCC; locally advanced BCC inappropriate for surgery or radiotherapy in adults. · This is a negative NICE recommendation in England/Wales context, not an MHRA label denial. It does not establish Scotland/Northern Ireland status, private access, or later appraisals of cemiplimab/sonidegib. Existing patients started before guidance publication may have different funding arrangements as NICE states. Confidence/conflicts: High for NICE vismodegib non-recommendation; UK cemiplimab/sonidegib status remains active gap.
  • Vismodegib (Erivedge); best supportive care comparator context[4]ApprovedNo biomarker requirement stated in fetched NICE recommendation; Symptomatic metastatic BCC; locally advanced BCC inappropriate for surgery or radiotherapy in adults. · This is a negative NICE recommendation in England/Wales context, not an MHRA label denial. It does not establish Scotland/Northern Ireland status, private access, or later appraisals of cemiplimab/sonidegib. Existing patients started before guidance publication may have different funding arrangements as NICE states. Confidence/conflicts: High for NICE vismodegib non-recommendation; UK cemiplimab/sonidegib status remains active gap.

출처

  1. National Cancer Institute (NCI) — national cancer agency news / FDA approval context · national cancer agency news / FDA approval context
  2. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  3. NICE — technology appraisal recommendation · technology appraisal recommendation
  4. NICE — technology appraisal recommendation · technology appraisal recommendation

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.