FDA approves Iclusig(Ariad Pharma) for CML and Ph+ ALL

Ariad Pharmaceuticals Inc. announced that following a priority review, the FDA on 14 December 2012, has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase Chronic Myeloid Leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

Ariad Pharmaceuticals has submitted its marketing authorisation application to the European Medicines Agency for ponatinib for resistant or intolerant Chronic Myeloid Leukaemia and Philadelphia-chromosome positive Acute Lymphoblastic Leukaemia and has secured an accelerated assessment of the application.