FDA move allows Ariad Pharmaceuticals' resumed marketing of Iclusig

Agency approves new prescribing information, REMS for leukemia drug

CAMBRIDGE, Mass. — The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

Ariad said the FDA approved revised prescribing information and a risk evaluation and mitigation strategy, or REMS, for Iclusig (ponatinib) in refractory Philadelphia chromosome-positive, or Ph+ leukemias. These conditions include T315I-positive chronic myeloid leukemia; T315I-positive Ph+ acute lymphoblastic leukemia; and chronic-phase, accelerated-phase or blast-phase chronic myeloid leukemia; or Ph+ acute lymphoblastic leukemia in patients for whom no other similar therapy can be used.

"In less than two months of suspending marketing and commercial distribution of Iclusig in the [United States], we addressed the issues raised by the FDA and now are able to market and distribute Iclusig again in the [United States]," Ariad chairman and CEO Harvey Berger said. "As we look ahead to relaunching Iclusig in the [United States] and fulfilling our post-marketing requirements, we will continue to focus on understanding the benefits and risks of Iclusig treatment in patients with resistant or intolerant Philadelphia-positive leukemias."


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