AP 26113 (brigatinib) filed with FDA in a rolling submission for ALK+ non-small cell lung cancer - ARIAD Pharmaceuticals

ARIAD Pharmaceuticals announced the initiation of a New Drug Application (NDA) submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor AP 26113 (brigatinib) to the FDA, for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC.

The Company is seeking accelerated approval for brigatinib from the FDA and plans to request a priority review of the application. ARIAD's NDA is a rolling submission which will occur in three parts. The initial submission contains all nonclinical portions of the NDA and will be followed by submissions of the chemistry, manufacturing and controls (CMC) and clinical data. The rolling NDA submission is expected to be complete in the third quarter of 2016.

Comment: Brigatinib is currently being evaluated in the global Phase II ALTA trial that is the basis for its initial regulatory review. ARIAD has also initiated the Phase III ALTA 1L trial to assess the efficacy of brigatinib in comparison to crizotinib.