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# FDA Approves Xcovery’s Ensacove for Some Lung Cancers
- URL: https://www.fdaweb.com/fda-approves-xcoverys-ensacove-for-some-lung-cancers/
- Published: 2025-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:49:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158370

FDA has approved Xcovery Holding’s Ensacove (ensartinib) for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor. An agency [statement](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ensartinib-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer?ref=fdaweb.com) says efficacy was evaluated in the eXALT3 trial in 290 patients who were randomized to receive either ensartinib or crizotinib (Pfizer’s Xalkori).

The main efficacy outcome measure was progression-free survival, FDA says, as evaluated by blinded independent central review. The key secondary outcome measure was overall survival. The most common adverse reactions were rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia, and fatigue.

Xcovery [describes](https://www.morningstar.com/news/business-wire/20241218355621/fda-approval-of-ensartinib-for-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer-nsclc?ref=fdaweb.com) Ensacove as a next-generation ALK inhibitor it developed jointly with Betta Pharmaceuticals.