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.

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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.