Brigatinib NDA Granted Priority Review by FDA

The U.S. Food and Drug Administration has accepted for review the New Drug Application (NDA) for brigatinib as treatment for metastatic, ALK-positive non-small cell lung cancer (NSCLC) that progressed with crizotinib, and has granted ARIAD’s request for Priority Review of the NDA.¹

The NDA submission is based on data from a phase 1/2 trial and the pivotal phase 2 ALTA trial, which evaluated the activity and safety of brigatinib among patients with locally advanced or metastatic ALK-positive NSCLC previously treated with crizotinib.

Preliminary results of the ALTA study showed an objective response rate of 54% in patients who received brigatinib, with a median progression-free survival of 12.9 months.

The FDA is required to take action on the NDA by April 29, 2017, 6 months from the filing of the application, rather than the 10 months required under standard review.

Brigatinib has also previously received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK-positive NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation for ALK-positive, ROS1-positive, and EGFR-positive NSCLC.           

Reference

1. ARIAD announces U.S. Food and Drug Administration acceptance of NDA filing for brigatinib. ARIAD website. http://investor.ariad.com/phoenix.zhtml?c=118422&p=RssLanding&cat=news&id=2217368. Updated October 31, 2016. Accessed November 1, 2016.