ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the European Commission (EC) has 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.
“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 leukaemia patients as quickly as possible,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “The clinical development of Iclusig involved many leukaemia 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.”
The most common (>1%) serious adverse reactions for Iclusig were pancreatitis, abdominal pain, pyrexia, anaemia, febrile neutropenia, decrease in platelet count and neutrophil count, pancytopenia, myocardial infarction, diarrhea, and increased lipase. The most common (≥20%) adverse reactions of any severity were decrease in platelet count, rash, dry skin, and abdominal pain. There were no new safety signals observed with Iclusig when compared to the other approved products from the same class (BCR-ABL inhibitors).
ARIAD was granted accelerated assessment by the Committee for Medicinal Products for Human Use for the Iclusig marketing authorization application. The aim of accelerated assessment is to expedite the review process for new medicines that address a major public-health interest. Accelerated assessment is reserved for innovative products that respond to an unmet medical need and that are expected to have a major impact on medical practice.