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# FDA Accepts Ariad NDA for Lung Cancer
- URL: https://www.fdaweb.com/fda-accepts-ariad-nda-for-lung-cancer/
- Published: 2016-11-01T12:00:00.000Z
- Updated: 2026-09-14T21:44:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137228

FDA has accepted for review an Ariad Pharmaceuticals NDA for brigatinib, an investigational oral anaplastic lymphoma kinase (ALK) inhibitor for use in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The agency granted a priority review and set a user fee review target date of 4/29/2017\. The submission includes clinical data from the company’s Phase 1-2 and pivotal Phase 2 ALTA trials. Ariad has also initiated the Phase 3 ALTA 1L trial to assess the efficacy and safety of brigatinib in comparison to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor.