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FDA to Hear Appeal on Breast Cancer Drug
Date:6/28/2011

groups of patients who may benefit.

"FDA is ready to work with Genentech on any proposals to conduct additional studies in metastatic breast cancer designed to identify responsive tumors," Woodcock added at the time.

Avastin was OK'd in 2008 for use in conjunction with chemotherapy under the FDA's accelerated approval program. Approval was based on one clinical trial of patients with metastatic HER2-negative breast cancer that found a benefit in terms 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; Associated Press


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