FDA Drops Approval of Avastin for Breast Cancer

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.”

“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. (More FDA stories.)