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FDA OKs Avastin for Advanced Breast Cancer
Date:2/22/2008

Drug has significant risks, experts say

FRIDAY, Feb. 22 (HealthDay News) -- The U.S. Food and Drug Administration went against the recommendation of its own advisory panel on Friday and approved the cancer drug Avastin for women with advanced breast cancer.

The agency cleared the drug, made by Genentech and already approved for treating lung and colon cancer, based on findings that it slowed tumor growth, the Associated Press reported.

In a prepared statement issued Friday afternoon, Genentech said the drug won accelerated approval "in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. The approval is based on a Phase III study, called E2100, that showed that Avastin in combination with paclitaxel chemotherapy resulted in a 52 percent reduction in the risk of disease progression or death compared to those treated with paclitaxel alone and a doubling in progression-free survival."

"There is no cure for metastatic breast cancer, so it is important to control the disease as early and for as long as possible," Dr. Kathy Miller, lead investigator on the E2100 trial, said in the Genentech statement. "Now with Avastin plus paclitaxel, we can increase the time a womans cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone," added Miller, an associate professor of medical oncology at Indiana University School of Medicine.

Last December, an expert panel of advisers to the FDA voted 5-4 that the drug's ability to slow down the growth of tumors did not outweigh the increased risk of blood clots and other cardiovascular troubles among users. In rare cases, patients taking Avastin with standard chemotherapy have died.

"Everybody wants to offer metastatic breast cancer patients hope, but we shouldn't offer them false hope," panel mem
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