FDA Approves Ariad’s Iclusig For Two Rare Types of Leukemia

The Food and Drug Administration Dec. 14 approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL), two rare blood and bone marrow diseases.

Iclusig, which is marketed by Cambridge, Mass.-based Ariad Pharmaceuticals Inc., is being approved more than three months ahead of the product’s Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2013, the agency said. FDA reviewed the Iclusig drug application under the agency’s priority review program, which provides for an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative ...