Tumor-agnostic / NTRK fusion-positive solid tumors: options by country
Sourced options by country plus visit-prep questions for Tumor-agnostic / NTRK fusion-positive solid tumors. Each line links to its regulator, HTA, or guideline source. This page maps options; it does not recommend or rank them.
Options mappedRare diseaseLast checked June 2026
What this page does
Maps options by country
It maps sourced options by country alongside diagnosis wording, stage, test results, specialists, and trial-search terms.
What it does not do
Does not choose treatment
It does not rank treatments, recommend a choice, or decide clinical fit.
Where it comes from
Built on trusted sources
Every option links to a trusted regulator, HTA, or guideline source, and the list grows as new sources pass verification.
Information to gather before the next visit
Which NTRK fusion test result and resistance-mutation status are documented?
Which FDA-approved TRK inhibitor fits the age, prior-treatment, CNS, and prior-TRK-inhibitor context?
Are there trial options after progression on a first TRK inhibitor?
Does the local EU country reimburse Vitrakvi or Rozlytrek for this tumor type and age group?
Regulatory and access status by country, from official sources. It shows what exists and where — not a recommendation.
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.
This is official regulatory and access status only — not medical advice, not a recommendation, and not a statement about eligibility. Whether any option fits depends on your situation and your oncology team. Status changes over time; confirm the current position with the linked source. Last checked 2026-06-12.