Iclusig ponatinib regulatory update

The European Commission approved Iclusig ponatinib from Ariad 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.

In December, FDA granted accelerated approval to Iclusig for CML and Ph+ ALL that is resistant or intolerant to prior treatment with tyrosine kinase inhibitors (TKIs) (see BioCentury, Dec. 17, 2012). The pan-BCR-ABL TKI has Orphan Drug status to treat CML and Ph+ ALL in the U.S., and Orphan Drug status for CML and ALL in the EU. ...