OnCo
drugsProductNot mapped hereapproved

Entrectinib

Entrectinib (Rozlytrek) is a pill for NTRK-fusion cancers and ROS1 lung cancer that reaches brain metastases.

STARTRK-2/ALKA/STARTRK-1 integrated analysis: 57% response in NTRK fusion tumours, 77% in ROS1+ NSCLC, with intracranial activity. Approved August 2019 (Japan June 2019). Weight gain, dizziness, cognitive effects and cardiac failure are class-related TRK toxicities. Paediatric label extension 2023.

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Entrectinib
PubChem
Modality
Small-molecule TRK/ROS1/ALK TKI (CNS-penetrant)
Mechanism
Multikinase inhibitor of TRKA/B/C, ROS1 and ALK designed to cross the blood-brain barrier.
Brand / code
Rozlytrek
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 or ROS1 rearrangement 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 TA643 · 2020SMC: accepted
Appraised for
NTRK fusion-positive solid tumours (histology-independent)
Notes
ROS1-positive NSCLC: TA644 (2020). The first tumour-agnostic appraisals in NICE's history.
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 TA643 · NHS England Cancer Drugs Fund list · SMC advice: entrectinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
JP2019NTRK fusion solid tumours
US2019ROS1-positive metastatic NSCLC; NTRK fusion solid tumours (≥12 years, extended to ≥1 month 2023)
EU2020Same

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Entrectinib
intervention: Entrectinib
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:"Entrectinib" OR ABSTRACT:"Entrectinib" OR TITLE:"Rozlytrek" OR ABSTRACT:"Rozlytrek") 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 Entrectinib, not a curated reading list.

Connected

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