FDA grants Iclusig (ponatinib) full approval for chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia, for T315I-positive CML or T315I positive Ph+ ALL- Ariad Pharma

ARIAD Pharmaceuticals announced that the FDA has granted Iclusig (ponatinib) full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved in December 2012 under the FDA's accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drug's clinical benefit.

This full approval and label update is based on 48-month follow-up data (as of August 2015) from the pivotal Phase II PACE clinical trial of Iclusig in heavily pretreated patients with resistant or intolerant CML or Ph+ ALL. These data were presented at the 2016 meetings of the American Society for Clinical Oncology and the European Hematology Association (EHA).