FDA revokes breast cancer approval for Avastin

Approvals for other cancers to remain in place

SILVER SPRING, Md. — A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

The FDA announced that it would revoke the agency's approval of Genentech's Avastin (bevacizumab) for breast cancer. The drug's approval for cancers of the colon, lungs, kidney and brain will remain in place. The agency proposed withdrawing the approval in December 2010, just months after an advisory committee recommended limiting its use for breast cancer, after reviewing results from four clinical studies indicating that the drug "does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients."

"This was a difficult decision," FDA commissioner Margaret Hamburg said. "FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use."

The agency approved Avastin for breast cancer that had spread to other parts of the body in February 2008, under the agency's accelerated approval program. But Friday's decision, based on thousands of pages from a public docket, from clinical trials and from a two-day hearing in June — scheduled at the request of Genentech when the company was informed that the agency was considering revoking the breast-cancer approval — resulted in the FDA's Oncologic Drugs Advisory Committee voting unanimously in favor of withdrawal.

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