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Trials & Filings

Ariad Suspends Iclusig Marketing

Tox concerns shelve CML treatment until REMS sorted out

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Ariad Pharmaceuticals has temporarily suspended the marketing and commercial distribution of Iclusig (ponatinib), a treatment for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), in the U.S.

The company is negotiating with the FDA updates to the U.S. prescribing information for Iclusig and implementation of a risk mitigation strategy. An increase in arterial thrombosis among patients has led to toxicity concerns from the FDA. On October 9, the FDA placed a partial clinical hold on all studies of Iclusig, and on October 18, Ariad cancelled a Phase III trial of the drug as a first-line treatment for newly diagnosed leukemia patients.

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