선택지 정리됨

Tumor-agnostic / NTRK fusion-positive solid tumors: 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

Tumor-agnostic / NTRK fusion-positive solid tumors 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

larotrectinib (Vitrakvi); entrectinib (Rozlytrek); repotrectinib (Augtyro)[1]FDA-approvedNTRK gene fusion without a known acquired resistance mutation where specified by FDA sources; Larotrectinib: metastatic or severe-morbidity surgery setting with no satisfactory alternatives or progression after treatment. Entrectinib: spread/cannot be removed by surgery and prior standard treatment per NCI FDA summary; pediatric expansion to patients as young as 1 month noted. Repotrectinib: adult and pediatric patients 12 years and older with locally advanced/metastatic or severe-morbidity surgery setting that has progressed following treatment or has no satisfactory alternative therapy. · FDA larotrectinib source was the original accelerated approval notice; a separate fetched Bayer/FDA-linked news source states full U.S. approval in 2025 but is not the FDA page itself. Entrectinib and repotrectinib indications include accelerated-approval contexts in fetched sources. Confidence/conflicts: High confidence for FDA-approved status of the named agents; medium caveat on larotrectinib full-approval date because the fetched FDA page was the original accelerated approval while the fetched full-approval source was manufacturer-hosted. No direct conflict found.

European Union

larotrectinib (Vitrakvi); entrectinib (Rozlytrek)[2]EMA authorisedNTRK gene fusion; Advanced/metastatic/not amenable to surgery with no satisfactory alternatives for larotrectinib; metastatic or severe-harm surgery setting, no prior same-mechanism therapy, and unsuitable other treatments for entrectinib. · EMA authorization does not determine Germany/France reimbursement, local availability, or individual eligibility; member-state access requires separate confirmation. Confidence/conflicts: High confidence for EMA-approved status and indication wording in fetched EPAR overview lines; no conflicting fetched source. National reimbursement remains unresolved.

United Kingdom

larotrectinib (Vitrakvi); entrectinib (Rozlytrek)[3]ApprovedNTRK fusion-positive; Larotrectinib for NTRK fusion-positive solid tumours in adults and children per TA630 overview; entrectinib for NTRK fusion-positive solid tumours in people 12 years and over per terminated TA1118 scope. · NICE technology appraisals are reimbursement/access guidance, not MHRA marketing authorization text. Scotland, Wales implementation, private access, and current local CDF criteria need separate local confirmation. Confidence/conflicts: High confidence for NICE access/reimbursement statements. UK-wide availability beyond NICE England-Wales context not established.

Japan

entrectinib (Rozlytrek)[4]PMDA-approved (Japan)NTRK fusion-positive; Advanced/recurrent solid tumors with NTRK fusion-positive status; PMDA notes limits including no established adjuvant-therapy evidence following surgery. · Fetched PMDA source is the review report, not a live reimbursement listing. Larotrectinib Japan approval was not verified from a regulator source in this pass. Confidence/conflicts: High confidence for Japan entrectinib approval/PMDA positioning. Larotrectinib Japan status remains source-pending from official sources.

China

larotrectinib (Vitrakvi)[5]NMPA-approved (China)NTRK gene fusion, identified by a sufficiently validated test per fetched source; Adult and pediatric patients with advanced solid tumors harboring an NTRK gene fusion, as reported by the fetched source. · Source is secondary medical news reporting Bayer's announcement, not a primary NMPA record; treat as medium-confidence until an official Chinese regulator or product-label source is fetched. Entrectinib China treatment approval was not verified from an accessible source this pass. Confidence/conflicts: Medium confidence because the fetched source reports NMPA approval but is not the regulator. No conflicting fetched source; primary NMPA verification remains a gap. Availability/reimbursement outside the approving regulator not established.

출처

U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
European Medicines Agency — regulator EPAR · regulator EPAR
NICE — health technology appraisal · health technology appraisal
Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
Medthority — medical news / manufacturer-announcement report · medical news / manufacturer-announcement report

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.