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FDA Advises Against Avastin as Treatment for Breast Cancer
Date:12/16/2010

By Amanda Gardner
HealthDay Reporter

THURSDAY, Dec. 16 (HealthDay News) -- Federal health officials on Thursday recommended revoking approval of the drug Avastin to fight breast cancer, citing the medication's poor performance in follow-up studies and its potential for serious side effects.

But the recommendation, announced by U.S. Food and Drug Administration (FDA) officials at a news conference, will not immediately affect breast cancer patients' access to the drug or limit use of the Avastin (bevacizumab) for advanced colon, lung, kidney and brain cancer.

Nevertheless, the decision could leave breast cancer patients who have responded well to the drug wondering what to do next.

"FDA has taken the first step to removing the breast cancer indication from the label of the cancer drug Avastin," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), announced at the news conference. "This is a first step in a process and will not have an immediate impact on use of Avastin or the drug's availability."

"Oncologists currently treating patients with Avastin should use medical judgment in deciding whether to continue treatment or explore other treatment options," she added.

The drug's maker, Genentech, has been notified of the recommendation in writing and now has 15 days to request a proceeding to dispute the FDA recommendation and present additional evidence. The company "has not agreed to remove the breast cancer indication voluntarily," the FDA noted in a statement released Thursday.

Some doctors expressed concern at the decision.

"This is a tough issue. There are women who have clearly responded to the treatment, [and] this is going to be a very difficult pill to swallow for those women," said Dr. Neil Spector, professor of medicine at Duke Cancer Institute in Durham, N.C.

"There's a very real possibility that there may be a subgroup of women that
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