Ariad's Cancer Drug Iclusig Backed By CHMP

Global oncology biotech firm Ariad Pharmaceuticals announced that it has received the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the continued use of Iclusig (ponatinib) as treatment for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia in the EU.

Iclusig is a kinase inhibitor that primarily targets BCR-ABL, an abnormal tyrosine kinase expressed in CML and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The U.S. Food and Drug Administration (FDA) briefly suspended Iclusig in the U.S. last December due to its association with risks of blood clots and artery blockage. However, the drug was allowed back in the market in January following the FDA’s approval of revised prescribing information which updated safety data and dosing recommendations.

“Over the past year, we have closely monitored patients on Iclusig and are confident that the updated safety information will help us provide this important therapy to patients who have become resistant or intolerant to certain other tyrosine-kinase inhibitors. The flexibility to reduce the dose after achievement of response is an important factor for physicians in treating CML patients with Iclusig,” said Giuseppe Saglio, professor of internal medicine and hematology at the University of Turin in Italy.

The EMA and CHMP’s positive opinion to allow the continued use of the drug in the EU follows that of the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC conducted an 11-month review of the drug’s available data and stated that Iclusig’s benefits continue to overweigh risks in each of its indications. The EMA recommended that the drug’s label include warnings to minimize the risk of vascular events.

“We are now well positioned to complete pricing and reimbursement negotiations in Europe and to ensure that Iclusig is available to appropriate Philadelphia-chromosome positive leukemia patients. The authorized indications and the favorable benefit-risk balance of Iclusig give healthcare providers the ability to optimize the use of Iclusig in patients with resistant or intolerant CML,” said Jonathan E. Dickinson, general manager, ARIAD Pharmaceuticals in the EU.

The company said it expects the European Commission to give its final decision regarding continued use of Iclusig in the EU by the end of 2014.