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Breast Cancer Drug Not Safe, Says FDA

Despite drug company’s and patients’ pleading, an FDA panel votes to rescind Avastin approval for breast cancer.

By | June 30, 2011

image: Breast Cancer Drug Not Safe, Says FDA cancer.gov

CANCER.GOV

At the end of an emotional two-day hearing, an FDA advisory committee voted 6-0 yesterday (June 29) that Genentech’s Avastin should no longer be approved for the treatment of advanced breast cancer. The FDA decided to withdrawal the approval back in December, but gave Genentech an unprecedented chance this week to change their minds, ScienceInsider reports.

During the proceedings, the FDA laid out their case that Avastin is neither safe nor effective for the treatment of breast cancer, with serious side effects including high blood pressure, bleeding and hemorrhage. Breast cancer patients pleaded with the FDA that the drug had saved their lives, and Genentech, the drug’s manufacturer, proposed a compromise—to run another clinical trial while approval stayed in place, notes the New York Times. But the FDA denied the deal, opting to send a recommendation to FDA Commissioner Margaret Hamburg to suspend marketing of Avastin for breast cancer. When Hamburg will make the final decision is unknown, reports WebMD Health News.

The drug will not be removed from the market, and is still approved for use in colon, kidney, brain, and lung cancers.

 

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