Less than a year after the Food and Drug Administration (FDA) approved Ariad Pharmaceutical’s leukemia drug Iclusig (ponatinib), the drug company announced it was suspending sales of the drug because of a greater risk for blood clots.
Iclusig was approved to treat two rare types of leukemia, chronic myeloid leukemia and acute myeloid leukemia. About 5,000 people are diagnosed with chronic myeloid leukemia each year. When the FDA approved the drug late last year, the agency required that the drug’s label include a black box warning for potentially serious side effects including blood clots and liver toxicity.
The FDA had intended to hold off on a decision for approving the drug until late March 2013, but opted to approve it much sooner with the boxed warnings. The approval committee at the time felt physicians prescribing the drug would already be familiar with adverse effects caused by the disease and prior treatment and would weight the potential risks against the potential benefits of the drug.
Last month, Ariad Pharmaceuticals disclosed a higher rate of blood clots from Iclusig. The data showed 11.8 percent of patients treated with the drug suffered a serious blood clot in an artery over a two-year period, much worse than previous statistics that showed an eight percent risk of blood clots after 11 months.
Based on the data, the FDA asked the drug company to stop marketing the drug. Ariad Pharmaceuticals is working with the FDA about changing the prescribing information and finding new ways to manage the blood clot risk with Iclusig. The company hopes to reintroduce the drug as soon as it reaches an agreement with the FDA.
In the meantime, the FDA has halted enrollment of patients in new studies on the drug, and the drug company says it will end a late-stage trial currently in progress.