Priority Review for Ariad's brigatinib

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) said FDA accepted and granted Priority Review to an NDA for brigatinib ( AP26113) to treat metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients who have progressed on Xalkori crizotinib. Its PDUFA date is April 29, 2017.

In the U.S., brigatinib has breakthrough therapy designation to treat ALK-positive NSCLC in patients whose tumors are resistant to Xalkori, as well as Orphan Drug designation to treat ALK-positive, c-ros proto-oncogene 1 receptor tyrosine kinase ( ROS1)-positive and EGFR-positive NSCLC. Brigatinib is a dual inhibitor of ALK and EGFR. ...