ARIAD Pharma Reports Submission Of MAA For Brigatinib To EMA

(RTTNews) - ARIAD Pharmaceuticals Inc. (ARIA) announced the submission of a Marketing Authorization Application (MAA) for its investigational oral anaplastic lymphoma kinase or ALK inhibitor, brigatinib, to the European Medicines Agency or EMA.

ARIAD is seeking marketing approval in the European Union of brigatinib in adult patients with anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been previously treated with crizotinib.

The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application for brigatinib filed by ARIAD and has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA).

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+, ROS1+ and EGFR+ NSCLC.