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A Chinese-developed ALK pill approved in the US in December 2024 for first-line ALK-positive lung cancer.
Ensartinib is a potent second-generation ALK tyrosine kinase inhibitor with activity against crizotinib-resistant mutations and penetration into the central nervous system. In the eXalt3 trial (JAMA Oncology 2021) it beat crizotinib in ALK-TKI-naive NSCLC, with median progression-free survival of 25.8 versus 12.7 months. It was approved in China in 2020 for use after crizotinib and in 2022 for first-line treatment, and the FDA approved it in December 2024 for ALK-inhibitor-naive locally advanced or metastatic disease, developed in the US by Xcovery. Rash is its characteristic toxicity, in contrast to the pulmonary events of brigatinib or the metabolic effects of lorlatinib. It has not been compared directly with alectinib or lorlatinib, so its place among first-line ALK drugs is still being worked out. Ensartinib adds a further option to an already crowded class.
Potent ALK inhibitor with activity against crizotinib-resistant mutations and CNS penetration. Connects to ALK.
1.Ensartinib slips into a pocket on ALK.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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.
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.
Sources: NICE search: ensartinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| CN | 2020 | ALK-positive NSCLC after crizotinib |
| US | 2024 | ALK-positive locally advanced or metastatic NSCLC, ALK-inhibitor-naive |
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Query 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.
Shares Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations, Betta Pharmaceuticals, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares Xcovery, Non-small-cell lung cancer.
Shares ALK-positive non-small-cell lung cancer, ALK, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares ALK fusion (ALK-positive), ALK-positive non-small-cell lung cancer, ALK, Small-molecule kinase inhibitors.
Shares Betta Pharmaceuticals, ALK-positive non-small-cell lung cancer.
Shares eXalt3, ALK-positive non-small-cell lung cancer, ALK, Small-molecule kinase inhibitors.
Shares Betta Pharmaceuticals, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares eXalt3, ALK-positive non-small-cell lung cancer, ALK, Small-molecule kinase inhibitors.