BioCentury
ARTICLE | Clinical News

Iclusig ponatinib regulatory update

November 11, 2013 8:00 AM UTC

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) said patients and healthcare professionals may continue to use leukemia drug Iclusig ponatinib from Ariad, but with "increased caution" and careful monitoring for thromboembolism and vascular occlusion. PRAC recommended updating Iclusig's product information to include strengthened warnings on the cardiovascular risk and guidance on optimizing CV therapy prior to starting Iclusig. EMA's CHMP will consider PRAC's recommendation at its Nov. 18-21 meeting. Earlier this month, EMA said it was reviewing data on the risk of arterial thrombosis with Iclusig (see BioCentury, Nov. 4). In October, Ariad said it would temporarily suspend U.S. marketing and distribution of Iclusig at FDA's request due to the risk of arterial thrombotic events. Earlier in October, FDA had placed a partial clinical hold on all trials of Iclusig due to arterial thrombotic events observed in patients treated with the drug (see BioCentury, Oct. 21).

The European Commission approved Iclusig in July to treat chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Iclusig is approved to treat chronic, accelerated or blast phase 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 Ph+ 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 (see BioCentury, July 15). Iclusig has accelerated approval from FDA for CML and Ph+ ALL that is resistant or intolerant to prior treatment with TKIs (see BioCentury, Dec. 17, 2012). 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. ...