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국가별 치료 선택지

어떤 선택지가, 어디에서.

규제·평가 기관 승인은 국가마다 다릅니다. 같은 약이 한 나라에서는 승인되고 다른 나라에서는 승인되지 않을 수 있습니다. 이 페이지는 암종별로 출처와 함께 그 상태를 정리합니다 — 추천이나 적격성 판단이 아닙니다. 임상 세부 내용은 영문이 정본입니다.

국가별 선택지

Melanoma (cutaneous) · Uveal melanoma

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

Melanoma (cutaneous)

United States

  • lifileucel (Amtagvi)[1]FDA-approved (accelerated approval)unresectable or metastatic melanoma, adults, after prior PD-1 blockade; if BRAF V600-positive, after a BRAF inhibitor with or without a MEK inhibitor · Accelerated approval; prescribing information includes a boxed warning. Not indicated for untreated melanoma.
  • encorafenib (Braftovi) + binimetinib (Mektovi)[2]FDA-approvedunresectable or metastatic melanoma with a BRAF V600E or V600K mutation detected by an FDA-approved test · Not indicated for wild-type BRAF melanoma; confirm BRAF V600E/V600K mutation before initiation.

European Union

  • nivolumab + relatlimab (Opdualag)[6]EMA-authorised (central marketing authorisation)first-line advanced unresectable or metastatic melanoma, adults and adolescents 12 years and older, tumour-cell PD-L1 expression less than 1% · Central EU authorisation only (under additional monitoring); member-state reimbursement (e.g. Germany/France) not verified.
  • binimetinib (Mektovi) + encorafenib (Braftovi)[7]EMA-authorised (central marketing authorisation)unresectable or metastatic melanoma with a BRAF V600 mutation, adults · Central EU authorisation only; member-state reimbursement (e.g. Germany/France) not verified.
  • lifileucel (Amtagvi)[8]EMA: not authorised (marketing authorisation application withdrawn 2025-07-22)intended use was unresectable or metastatic melanoma in adults after prior PD-1 blockade (and, if BRAF V600-mutated, a BRAF inhibitor with or without a MEK inhibitor) · Application withdrawn by Iovance Biotherapeutics B.V.; EMA's provisional opinion was that Amtagvi could not have been authorised. Not an available EU treatment option.

United Kingdom

  • nivolumab + relatlimab (Opdualag)[3]NICE-recommended on the NHS (England and Wales)untreated advanced unresectable or metastatic melanoma, people 12 years and over · Recommended only with a 2-year stopping rule (or earlier on progression) and under the commercial arrangement; NHS England/Wales context, not a universal UK availability statement.
  • nivolumab (Opdivo) + ipilimumab (Yervoy)[4]NICE-recommended on the NHS (England and Wales)advanced unresectable or metastatic melanoma, adults · Recommended within marketing authorisation, conditional on the agreed patient access scheme discount for ipilimumab.
  • encorafenib (Braftovi) + binimetinib (Mektovi)[5]NICE-recommended on the NHS (England and Wales)unresectable or metastatic BRAF V600 mutation-positive melanoma, adults · Recommended within marketing authorisation, only if both medicines are provided under the commercial arrangements.

Uveal melanoma

United States

  • Surgery (resection and enucleation)[11]NCI PDQ: listed among standard treatment optionsprimary intraocular/uveal melanoma; enucleation described when vision cannot be saved and the tumor is large, has spread to the optic nerve, or causes high intraocular pressure · PDQ is an information summary, not a patient-specific eligibility rule; choice depends on tumor size and extent.
  • Radiation therapy (plaque radiation therapy; external-beam charged-particle radiation therapy)[11]NCI PDQ: listed among standard treatment optionslocal treatment for intraocular/uveal melanoma, including medium-sized choroidal melanoma · Charged-particle radiation is offered at specialized referral centers; options differ by tumor extent and clinical factors.

European Union

  • tebentafusp (Kimmtrak)[9]EMA-authorised (central marketing authorisation)uveal melanoma that cannot be removed by surgery or has spread, adults · Central EU authorisation only; must be given where cytokine release syndrome can be managed; member-state reimbursement (e.g. Germany/France) not verified.

United Kingdom

  • tebentafusp (Kimmtrak)[10]NICE-recommended on the NHS (England and Wales)HLA-A*02:01-positive unresectable or metastatic uveal melanoma, adults · Recommended within marketing authorisation, only under the commercial arrangement; NHS access appraisal, not a universal UK availability statement.

출처

  1. FDA — accelerated approval notice (lifileucel) · FDA regulator approval notice
  2. FDA — Braftovi (encorafenib) drug label · FDA official drug label
  3. NICE TA950 · NICE health technology appraisal
  4. NICE TA400 · NICE health technology appraisal
  5. NICE TA562 · NICE health technology appraisal
  6. EMA EPAR — Opdualag · EMA EPAR
  7. EMA EPAR — Mektovi · EMA EPAR
  8. EMA EPAR — Amtagvi (withdrawn application) · EMA EPAR (withdrawn application)
  9. EMA EPAR — Kimmtrak · EMA EPAR
  10. NICE TA1027 · NICE health technology appraisal
  11. NCI PDQ — Intraocular (Uveal) Melanoma Treatment · NCI PDQ

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니며 적격성 판단도 아닙니다. 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.

Melanoma (cutaneous) 페이지로 이동 →

국가별 선택지

Non-small cell lung cancer

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

United States

  • lazertinib (Lazcluze) + amivantamab-vmjw (Rybrevant)[1]FDA-approvedfirst-line, locally advanced or metastatic, EGFR exon 19 deletion or exon 21 L858R substitution (detected by an FDA-approved test) · MARIPOSA enrolled patients with no prior systemic therapy for advanced disease; FDA approval summary notes a venous thromboembolic-event safety signal / prophylactic anticoagulation language.

European Union

  • lazertinib (Lazcluze) + amivantamab (Rybrevant)[2]EMA: authorised in the EUfirst-line, advanced, EGFR exon 19 deletion or exon 21 L858R substitution, adults · Used in combination with amivantamab (Rybrevant EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/rybrevant). EMA notes EGFR testing required before treatment and anticoagulation at initiation for VTE risk. Member-state reimbursement not verified.
  • lorlatinib (Lorviqua)[3]EMA: authorised in the EUadvanced, ALK-positive, adults; used on its own when not previously treated with an ALK tyrosine kinase inhibitor · Prescription-only; treatment started and supervised by a doctor experienced in cancer medicines. Member-state reimbursement not verified.

United Kingdom

  • amivantamab (Rybrevant) + lazertinib (Lazcluze)[4]NICE-recommended on the NHS (England and Wales), within marketing authorisationuntreated advanced, EGFR exon 19 deletion or exon 21 L858R substitution, adults · Recommended only if the companies provide the drugs according to the commercial arrangements; framed against usual osimertinib-based regimens.
  • lorlatinib (Lorviqua)[5]NICE-recommended on the NHS (England and Wales)advanced, ALK-positive, adults who have not had an ALK inhibitor · Citation updated from the now-superseded TA909 to the current NICE TA1103 (published 21 October 2025), which replaced it and carries the same recommendation for this indication. Recommended only if the company provides it according to the commercial arrangement; NHS England/Wales context, not a universal UK availability statement.
  • selpercatinib (Retsevmo)[6]NICE-recommended on the NHS (England and Wales)advanced, RET fusion-positive, previously treated but not with a RET inhibitor · TA1042 covers previously treated disease; untreated RET fusion-positive advanced NSCLC is addressed via a separate managed-access recommendation under NICE TA911 (https://www.nice.org.uk/guidance/ta911). Recommendation does not cover everyone licensed for selpercatinib.

출처

  1. FDA approval notice · regulator approval notice
  2. EMA EPAR — Lazcluze · regulator EPAR / product page
  3. EMA EPAR — Lorviqua · regulator EPAR / product page
  4. NICE TA1122 · HTA appraisal / guideline
  5. NICE TA1103 · HTA appraisal / guideline
  6. NICE TA1042 · HTA appraisal / guideline

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니며 적격성 판단도 아닙니다. 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.

Non-small cell lung cancer 페이지로 이동 →