The FDA grants full approval for ARIAD Pharmaceuticals' (ARIA +1.6%) Iclusig (ponatinib) for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) for whom no other TKI therapy is indicated and for the treatment of adult patients with T315I-positive CML or T315I-positive Ph+ acute lymphocytic leukemia.
The FDA initially OK'd Iclusig in December 2012 under its accelerated approval program.
The agency also approved an update to Iclusig's label to include 48-month follow-up data from the Phase 2 PACE study. The results confirmed the product's safety profile and long-term durability of response.
Enrollment is ongoing in a post-market dose-ranging study called OPTIC that will inform the optimal dosing of Iclusig. Top-line data will be submitted for presentation at next year's meeting of the American Society of Hematology (ASH).
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