Iclusig ponatinib regulatory update

Ariad said EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) requested additional information for Iclusig ponatinib as part of a review in the EU of the benefits and risks of the leukemia drug. The company said PRAC requested information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Ariad said it expects PRAC will complete its review and make final recommendations to EMA’s CHMP in October; the company previously expected a decision this month. In December, CHMP started an “in-depth review” of Iclusig at the request of the European Commission (see BioCentury, Nov. 25, 2013).

Iclusig is approved in the EU to treat chronic, accelerated or blast phase chronic myelogenous leukemia (CML) in patients 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 in patients who have the T315I variant of BCR-ABL tyrosine kinase. Iclusig also is approved for Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) patients who are resistant to or intolerant of dasatinib and for whom imatinib is not appropriate, or in patients who have the T315I variant. In the U.S., Iclusig is approved for chronic, accelerated or blast phase CML and Ph+ ALL in patients who have the T315I variant of BCR-ABL tyrosine kinase or in patients for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated. Iclusig is under review in Canada and Australia and has Orphan Drug status to treat CML and Ph+ ALL in the U.S. and EU. ...