Ariad's cancer drug Iclusig granted marketing authorization in the EU for leukemia

USA-based Ariad Pharmaceuticals (Nasdaq: ARIA) hsa announced that it has been granted a marketing authorization by the European Commission for Iclusig (ponatinib) as an orphan medicinal product for two indications of leukemia.

It will be granted the authorization in the European Union for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid ponatinib (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 also the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (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.

Harvey Berger, chairman and chief executive of Ariad, said:  “We are delighted by the rapid approval of Iclusig in Europe and will now work closely with the national health authorities to make Iclusig available to Philadelphia-positive leukemia patients as quickly as possible. The clinical development of Iclusig involved many leukemia experts throughout Europe, and we want to recognize their critical roles in bringing Iclusig to patients with resistant or intolerant CML and Ph+ ALL in the EU.”