Ensartinib
A Chinese-developed ALK pill approved in the US in December 2024 for first-line ALK-positive lung cancer.
eXalt3 (JAMA Oncol 2021): PFS 25.8 vs 12.7 months versus crizotinib in ALK-TKI-naive NSCLC. Approved in China 2020 (post-crizotinib), 2022 first line; US approval December 2024 (Xcovery). Rash is the characteristic toxicity.
- 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). FDA-approved December 2024.
- 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.
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.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: ensartinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| CN | 2020 | ALK-positive NSCLC after crizotinib |
| US | 2024 | ALK-positive locally advanced or metastatic NSCLC, ALK-inhibitor-naive |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Ensartinib" OR ABSTRACT:"Ensartinib" OR TITLE:"Ensacove" OR ABSTRACT:"Ensacove") 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 Ensartinib, not a curated reading list.