Ariad Pharma files MAA with EMA for brigatinib, an investigational oral anaplastic lymphoma kinase (ALK) inhibitor, to treat (ALK+) non-small cell lung cancer (NSCLC).
Ariad Pharmaceuticals, Inc. announced the submission of a Marketing Authorization Application (MAA) for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the European Medicines Agency (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 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).
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