ARIAD Initiates Submission of NDA for Brigatinib Ahead of Plan

ARIAD Pharmaceuticals, Inc.

revealed the initiation of a New Drug Application (NDA) submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the Food and Drug Administration. The company is seeking marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. ARIAD said that 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 regulator for the treatment of ALK+ NSCLC. The company indicated that it was seeking accelerated approval for brigatinib and plans to request a priority review of the application. The company's president and CEO, Paris Panayiotopoulos, commented, "We are ahead of our previously announced schedule for initiating the submission of our brigatinib NDA to the FDA and we are grateful to have breakthrough status from the FDA, which provides the opportunity to utilize the rolling submission process." He added that "If approved, we believe that brigatinib will become an important new medicine for ALK+ NSCLC patients who have become resistant or intolerant to prior crizotinib therapy and will offer additional hope to these patients and their families." On Thursday, the stock shed 1.47 percent.