OnCo
drugsProductNot mapped hereapproved

Larotrectinib

The first drug approved for a gene fusion regardless of where the cancer started; it works in about 75% of NTRK-fusion cancers, from infant fibrosarcoma to salivary and thyroid cancers.

Drilon (NEJM 2018): 75% response across 17 tumour types; approved November 2018 as the second tumour-agnostic approval (after pembrolizumab MSI-H). Long durability (median DOR >40 months in updates); resistance via NTRK solvent-front mutations (G595R) addressed by repotrectinib and next-generation TRK inhibitors. Paediatric formulation.

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Larotrectinib
PubChem
Modality
Small-molecule pan-TRK inhibitor (first generation)
Mechanism
Highly selective ATP-competitive inhibitor of TRKA/B/C (NTRK1/2/3) fusion kinases.
Brand / code
Vitrakvi
Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. NTRK fusion by an approved test.

Assistance programmes

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

Cancer Drugs FundNICE TA630 · 2020SMC: accepted
Appraised for
NTRK fusion-positive solid tumours (histology-independent)
Cancer Drugs Fund
Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA630 · NHS England Cancer Drugs Fund list · SMC advice: larotrectinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2018Solid tumours with NTRK gene fusion without known acquired resistance mutation, metastatic or unresectable, adults and children
EU2019Same

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
14 studies6 recruiting14 Phase 2
Search “Larotrectinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Larotrectinib
intervention: Larotrectinib
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Larotrectinib" OR ABSTRACT:"Larotrectinib" OR TITLE:"Vitrakvi" OR ABSTRACT:"Vitrakvi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Larotrectinib, not a curated reading list.

Connected

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