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# Ensartinib NDA Accepted for Lung Cancer
- URL: https://www.fdaweb.com/ensartinib-nda-accepted-for-lung-cancer/
- Published: 2024-03-13T12:00:00.000Z
- Updated: 2026-09-14T14:25:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156546

FDA has accepted for review an Xcovery Holdings NDA for ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor for treating adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The submission is based on data from the Phase 3 eXalt3 study evaluating ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC, according to the company. In the clinical trial, ensartinib “demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile,” Xcovery says. The agency has set a user fee review action target date of 12/28\. Ensartinib is a next-generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals.