Treats anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small…. NDA 218171, held by Xcovery. Ensartinib Hydrochloride.
As of Nov 14, 2026, NDA 218171 (Ensacove), held by Xcovery, was first approved by FDA on Dec 18, 2024, with 2 approved supplements and 0 published complete response letters.
ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test who have not previously received an ALK-inhibitor.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| EnsacoveEQ 25MG BASE · capsule;oral | Ensartinib Hydrochloride | RxReference drug |
| EnsacoveEQ 100MG BASE · capsule;oral | Ensartinib Hydrochloride | RxReference drug |
| Feb 26, 2026 | Supplement 3Labeling · Standard review | Approved | |
| Jan 8, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Dec 18, 2024 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
