The U.S. Food and Drug Administration has announced it is revoking approval for the drug Avastin (bevacizumab) for treating breast cancer.
In announcing the decision, FDA Commissioner Margaret A. Hamburg, M.D. indicated Avastin fails to meet the FDA's standards for safety and effectiveness in treating breast cancer.
Risks associated with Avastin include bleeding, hemorrhaging, perforations of tissue in the nose, stomach, and intestines; heart attack and heart failure.
The FDA approved Avastin for use in treating metastatic breast cancer in in 2008 under an accelerated approval program. Under this program, Avastin was approved based on promising early testing results, but the FDA had the option to revoke approval based on the outcome of ongoing clinical trials.
The decision to revoke Avastin's approval for treating breast cancer follows on the heels of trials, which showed only a small effect on tumor growth but did not demonstrate improvement in patients' quality of life compared to chemotherapy — at least not enough to justify the risks. The FDA has not changed its approval for Avastin for use in treating certain types of colon, lung, kidney and brain cancer.
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