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

erms of cancer recurrence -- but not overall survival -- and was contingent on further data to confirm the results.

Three subsequent studies failed to find an overall survival benefit and, in fact, showed less impressive improvements in survival involving no progression of cancer.

After reviewing all four studies, FDA concluded that "patients receiving Avastin did not live any longer than patients not treated with the drug and were at greater risk of severe side effects, some of which are unique to Avastin," Woodcock said.

"These include perforations of the nose, stomach and intestine, many of which can be life-threatening, as well as high blood pressure, heart attack or heart failure, wound-healing complications and organ damage or failure," she said.

More information

The U.S. National Cancer Institute has more on Avastin.

SOURCES: Neil Spector, M.D., professor of medicine, Duke Cancer Institute, Durham, N.C.; Dec. 16, 2010 teleconference with Janet Woodcock, M.D., director, U.S. Food and Drug Administration Center for Drug Evaluation and Research; Dec. 16, 2010, news release, Seattle Cancer Care Alliance


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