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# Ariad NDA Filed for Brigatinib in Lung Cancer Patients
- URL: https://www.fdaweb.com/ariad-nda-filed-for-brigatinib-in-lung-cancer-patients/
- Published: 2016-09-02T12:00:00.000Z
- Updated: 2026-09-14T21:29:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136693

Ariad Pharmaceuticals has completed a rolling NDA submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, for its use treating patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib. The company is seeking accelerated approval and has requested a priority review.

The submission is based on data from Ariad’s Phase 1/2 and pivotal Phase 2 ALTA trials in which patients who had experienced disease progression on crizotinib therapy were randomized to one of two brigatinib regimens. “With a median follow-up of 8.3 months, the data show that, for patients treated with the 180 mg regimen with a seven day lead-in at 90 mg (Arm B), 54% achieved an investigator-assessed confirmed objective response, the trial’s primary endpoint,” the company says. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months).