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Agency determines any benefit the drug provides does not outweigh serious risks in these patients

Thursday, December 16, 2010 (Last Updated: 12/17/2010)

THURSDAY, Dec. 16 (HealthDay News) -- The U.S. Food and Drug Administration has recommended that the breast cancer indication on the label for bevacizumab (Avastin) be removed because the drug has not been proven a safe and effective breast cancer treatment. The drug is manufactured by Genentech.

The agency decided to make the recommendation after reviewing the results of four clinical studies of bevacizumab in breast cancer patients. The FDA determined that the drug does not prolong overall survival in these patients or provide enough benefit in slowing disease progression to outweigh the risks. These risks include severe high blood pressure, bleeding and hemorrhage, development of perforations in the body, and heart failure or heart attack.

The FDA notes that this is just the first step in the process of removing the breast cancer indication from bevacizumab's label and that the drug is not being removed from the market. The decision does not affect the drug's approvals for treating colon, kidney, brain, and lung cancers.

"The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.

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Specialties Hematology & Oncology

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