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FDA Revokes Approval of Avastin for Breast Cancer
Date:11/21/2011

By Steven Reinberg
HealthDay Reporter

FRIDAY, Nov. 18 (HealthDay News) -- Saying the risks outweigh the benefits in patients with advanced breast cancer, U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg said on Friday that the agency has rescinded its approval of the cancer drug Avastin for that use.

Avastin (bevacizumab), however, will remain available for treating some types of colon, lung, kidney and brain cancer.

"Today, I am revoking the FDA's approval of the breast cancer indication for Avastin after concluding that the drug has not been shown to be safe and effective for that use," Hamburg said during a late morning press conference.

"Sometimes, despite the hopes of investigators, patients, industry, and even the FDA, the results of rigorous testing can be disappointing," she said. "This is the case with Avastin when used for the treatment of metastatic breast cancer."

The risks of Avastin include severe high blood pressure, bleeding, heart attack or heart failure and the development of perforations in different parts of the body such as the nose, stomach and intestines.

"These are considerable risks from taking Avastin, and can be justified only if there is good evidence that the use of the drug will benefit the patient," Hamburg said. "In breast cancer, it was clear that there was no proof of benefits that would justify the risks."

The FDA's decision was based on an expert panel's unanimous recommendation in June that the drug was not safe or effective when used for women with metastatic breast cancer. The drug had been approved for use along with the cancer drug Taxol (paclitaxel) for an aggressive type of breast cancer called HER2-negative breast cancer.

In 2008, Avastin was approved to treat metastatic breast cancer under the FDA's accelerated approval program, Hamburg said. Under this program, a drug can gain approval before final data on its safety
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