FDA Drops Approval of Avastin for Breast Cancer

Drug lacks benefits, but side effects are 'life-threatening': commissioner
By Matt Cantor,  Newser Staff
Posted Nov 18, 2011 11:22 AM CST
FDA Drops Approval of Avastin for Breast Cancer
US Food and Drug Administration (FDA) Commissioner Margaret Hamburg.   (Getty Images)

(Newser) – The Food and Drug Administration has reversed its approval of Avastin as a treatment for breast cancer, long the subject of controversy. The agency’s commissioner said the drug didn't help patients but could hurt them, the New York Times reports. “This was a difficult decision,” says Dr. Margaret Hamburg in a statement. But studies have made it “clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit.”

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“Nor is there evidence that use of Avastin will help them live longer or improve their quality of life,” she adds. Avastin is still FDA-approved for other cancers, and Medicare has previously said it would keep paying for its use against breast cancer. But other insurers may stop covering the $88,000-a-year medicine. FDA advisors unanimously recommended the move—which could cost Roche, the company that bought drug manufacturer Genentech, $1 billion, according to earlier estimates. But a large chunk of those losses may already have taken place as the drug’s popularity has fallen. Click through for more on the contentious decision. (Read more FDA stories.)

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