"Regulatory, financial blows for cancer drug maker Aveo" by Robert Weisman | Globe Staff, May 02, 2013
A panel of medical specialists recommended Thursday that the Food and Drug Administration reject a kidney cancer drug developed by Aveo Pharmaceuticals Inc., cutting the Cambridge company’s stock price nearly in half and dimming prospects for a medicine once considered promising for patients.
The surprise 13-to-1 vote against approving the experimental capsule, called tivozanib, delivered a blow to Aveo, which last fall restructured its operations to concentrate on the cancer drug. While the advisory panel’s action is not binding, the FDA rarely overrides such recommendations. The agency is expected to render its decision by July 28.
“This is disappointing for patients, because it would certainly be a step forward in quality of life,” said Dr. David F. McDermott, a kidney cancer specialist at Beth Israel Deaconess Medical Center in Boston and leader at the Dana-Farber Harvard Cancer Center, who advised Aveo on the drug. When it was given to a dozen patients locally to identify who might benefit, McDermott said, tivozanib proved as effective but less toxic than kidney cancer medicines now on the market.
But advisory panel members were concerned by the results of a late-stage clinical trial of 517 patients....
More than 60,000 Americans are diagnosed with kidney cancer each year and more than 13,600 die from it, according to the National Cancer Institute....
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