EC approves Ariad's Iclusig

The European Commission approved Iclusig ponatinib from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) 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.

FDA granted accelerated approval to Iclusig in December for CML and Ph+ ALL that is resistant or intolerant to prior treatment with tyrosine kinase inhibitors (TKIs). The product is a pan-BCR-ABL TKI. Ariad was off $0.12 to $19.41 on Tuesday (see BioCentury, Dec. 24, 2012). ...