Cancer Drug Iclusig Back on the Market After Brief Hiatus

Ariad Pharmaceuticals Friday resumed U.S. sales of its cancer-fighting drug Iclusig, following major safety concerns from 2013.

The drug is indicated to treat adults with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia, and carries a boxed warning of clotting and heart failure risks.

Last month, the FDA approved the drugmaker’s revised prescribing information and a risk evaluation and mitigation strategy for Iclusig (ponatinib) that allowed for the immediate resumption of its marketing and commercial distribution.

The FDA in October asked Ariad to halt sales of Iclusig, also placing a hold on all clinical trials for the drug after one-fifth of patients in a postmarket trial were found to have developed blood clots and narrowing of blood vessels that put them at higher risk for heart attacks and strokes.

“We are pleased to again have Iclusig commercially available to patients in the United States,” said Marty Duvall, Ariad’s executive vice president and chief commercial officer.

The drugmaker notes Iclusig’s starting dose will remain at 45 mg daily. — Nick Otto

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