Ariad begins submission of ponatinib NDA

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) began submission of a rolling NDA to FDA for ponatinib to treat resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The company, which requested Priority Review for the application, is seeking accelerated approval for ponatinib based largely on data from the pivotal Phase II PACE trial. In June, Ariad reported data showing that 54% of chronic phase CML patients who were resistant or intolerant to tyrosine kinase inhibitor therapy, including 70% of patients with the T315I variant of BCR-ABL tyrosine kinase, achieved a major cytogenetic response. Ariad's proposed indication includes, but is not limited to, patients with the T315I mutation.

Ariad plans to submit the final subset of CMC data this quarter to complete the application. Ariad expects a decision on the NDA in 1Q13. The company also plans to submit an MAA to EMA this quarter. Ponatinib is a pan-BCR-ABL tyrosine kinase inhibitor. ...