FDA OK's Iclusig's Return to Market

The U.S. Food and Drug Administration (FDA) has approved new safety measures to reduce the risk of potentially fatal vascular problems that, once in place, will allow Ariad Pharmaceuticals (Cambridge, MA) to resume selling its leukemia drug Iclusig (ponatinib).

On October 31, 2013, the FDA requested that Ariad suspend sales of the drug after standard safety monitoring revealed a significant increase in the number of patients experiencing blood clots and severely narrowed blood vessels compared with the number reported when the drug was approved in December 2012 (Cancer Discov 2014;4:6–7). Ariad complied with the request.

The new measures mean that fewer patients will be candidates for Iclusig. Its use will be limited to adults with T315I-positive chronic, accelerated, or blast phase chronic myeloid leukemia (CML) or T315I-positive, Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL), as well as adults with chronic, accelerated, or blast phase CML or Philadelphia chromosome–positive ALL for whom no other tyrosine kinase inhibitor therapy is indicated.

In addition, Ariad will revise Iclusig's label to highlight the risk of blood clots and narrowed blood vessels, complications that have occurred in at least 27% of patients who have taken the drug, according to the FDA. The company also will update its medication guide for patients.

Finally, Ariad must undertake a risk evaluation and mitigation strategy, which will include activities such as sending letters to likely prescribers and prominently posting information at scientific meetings, to alert health care professionals to the drug's risks.

Ariad said that it would start distributing Iclusig again in mid-January, and that it would continue to assess the drug's dose, efficacy, and toxicity in postmarket investigations.

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