Ponatinib Manufacturer Suspends Distribution

The clinical development of ponatinib was placed on hold in early October, while the FDA investigated the adverse events associated with the drug. This was shortly followed by the early termination of the phase III EPIC trial, which was examining ponatinib in the frontline setting for untreated patients with chronic myeloid leukemia (CML). The suspension in distribution followed discussions between the manufacturer, Ariad Pharmaceuticals, Inc., and the FDA.

The FDA will continue to evaluate whether the benefits of treatment outweigh the risks. At this point, an effective dose and duration of treatment has yet to be identified.

"We continue to work with the FDA to negotiate updates to the US prescribing information for Iclusig and implementation of a comprehensive risk mitigation strategy," Harvey J. Berger, MD, chairman and chief executive officer of Ariad, said in a webcast. "Dialogue with the FDA will continue. We believe there are patients for whom there is a positive risk-benefit profile."

Ponatinib was granted accelerated approval in December 2012 for patients with CML or Philadelphia chromosome–positive acute lymphoblastic leukemia. This approval was based on data from the phase II PACE trial, which enrolled patients who were resistant or intolerant to dasatinib or nilotinib, or harbored a T315I mutation.

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