Ponatinib (Ariad Pharma) filed at FDA for CML and Ph+ALL

Ariad Pharmaceuticals has announced the submission of a New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the FDA. Ariad is seeking U.S. marketing approval of ponatinib in patients with resistant or intolerant Chronic Myeloid Leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The company is seeking accelerated approval for ponatinib by the FDA and has requested a priority review of the application.