The October 2013 suspension of marketing and sales of ponatinib (Iclusig – Ariad) for treatment of leukemia1 has been lifted by the FDA, and the drug is expected to return to the market this month with narrower indications and heightened safety warnings.2 The reason for its suspension was a high incidence of thrombotic events, some of them fatal. The new indications limit use of the drug to patients with T315I-positive disease and those "for whom no other tyrosine kinase inhibitor is indicated," presumably because of resistance or intolerance.

1. In brief: ponatinib (Iclusig) marketing and sales suspended. Med Lett Drugs Ther 2013; 55:93.

2. FDA. FDA drug safety communication: FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketing. Available at www.fda.gov. Accessed January 10, 2014.