EU Starts In-Depth Review of Troubled Leukemia Drug

Nick Mulcahy

December 06, 2013

The European Medicines Agency (EMA) has announced that it has begun an in-depth review of the benefits and risks of the leukemia drug ponatinib (Iclusig, Ariad). The primary safety concerns are the risks for blood clots and blockages in the arteries or veins.

Last month, the EMA performed an initial review of updated clinical trial data for the tyrosine kinase inhibitor and decided to keep the drug on the market, but with a strong warning about potential cardiovascular adverse effects.

The updated data suggest that serious cardiovascular toxicities, including vascular occlusive events, are occurring at a rate higher than what was reported when it was approved as an orphan drug in the European Union in July.

The in-depth review was necessitated by a variety of issues, according to the EMA. These include the need for a better understanding of the nature, frequency, and severity of events obstructing the arteries or veins; the potential mechanism through which ponatinib leads to these adverse effects; and whether or not there is a need to revise the dosing recommendation of ponatinib.

In the United States, ponatinib was temporarily pulled from the market in October at the request of the US Food and Drug Administration, as reported by Medscape Medical News.

Until its in-depth review is completed, the EMA warns against use in patients who have had a heart attack or stroke in the past, and recommends that all patients on the drug be assessed for cardiovascular risks and that measures be taken to reduce such risks before and during treatment with ponatinib. The drug should be stopped immediately in any patient with signs of a blockage in the arteries or veins, according to the agency.

In Europe, ponatinib is approved to treat adults with chronic myeloid leukemia and patients with acute lymphoblastic leukemia who are Philadelphia-chromosome positive.

Ponatinib is indicated for use in patients who cannot tolerate or do not respond to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not considered appropriate. It is also for use in patients with a T315I mutation, which causes resistance to imatinib, dasatinib, and nilotinib.

Ponatinib works by blocking the tyrosine kinase Bcr-Abl, which is found in some receptors on the surface of leukemia cells, where it is involved in stimulating the cells to divide uncontrollably. By blocking Bcr-Abl, ponatinib helps to control the growth and spread of leukemia cells.

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