Iclusig (Ariad Pharma) EU approved for CML and Ph+ALL

Ariad Pharmaceuticals, Inc. announced that the European Commission (EC) has on 2 July 2013 granted a marketing authorization for Iclusig (ponatinib) as an orphan medicinal product for two indications: �The treatment of adult patients with chronic phase, accelerated phase or blast phase Chronic Myeloid Leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, and �The treatment of adult patients with Philadelphia-chromosome positive Acute Lymphoblastic Leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Iclusig gained Accelerated Approval in the US for these indications on 14 December 2012.