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Ponatinib safety concerns prompt FDA to suspend sales and marketing

KEY POINT

In a phase 2 trial in individuals with resistant chronic myeloid leukemia or acute lymphocytic leukemia, ponatinib (Iclusig—Ariad Pharmaceuticals) demonstrated significant activity in multiple disease stages and regardless of BCR–ABL kinase mutation status. However, FDA suspended marketing and sales of ponatinib on October 31, 2013 after ongoing safety monitoring revealed an increased frequency of blood clots and narrowing of blood vessels.

SOURCES

Cortes JE et al. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013;369:Epub ahead of print.

Groarke JD et al. Cancer-drug discovery and cardiovascular surveillance [perspective]. N Engl J Med. 2013;369:Epub ahead of print.

Doroshow JH. Overcoming resistance to targeted anticancer drugs [editorial]. N Engl J Med. 2013;369:Epub ahead of print.