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FDA Advisory Committee Votes Against Avastin

By a 5-4 vote, committee recommends against approving Avastin as breast cancer treatment

THURSDAY, Dec. 6 (HealthDay News) -- The U.S. Food and Drug Administration Oncology Drug Advisory Committee voted 5-4 on Wednesday against recommending that the drug Avastin (bevacizumab) be approved as a treatment for breast cancer. The non-binding vote will be considered when FDA regulators meet Feb. 23 to make their final decision.

Avastin, a monoclonal antibody, is already approved for treating patients with colon and non-small cell lung cancers. Avastin's manufacturer, Genentech, Inc., had asked the FDA to extend its approval to patients with locally recurrent or metastatic breast cancer, to be used in combination with paclitaxel. In weighing their decision, the advisory committee assessed Genentech data, which included a study of 722 patients showing that the addition of Avastin to paclitaxel increased median progression-free survival by 5.5 months. No significant effects were seen on overall survival, however. A second study had similar findings.

Significant safety concerns have emerged with the use of Avastin and an FDA staff review of the data found a 20.2 percent increase in grade 3 to 5 toxicities with the addition of Avastin to chemotherapy. Further noted was a 1.7 percent increased death rate in the Avastin/paclitaxel trial for those on combination therapy compared to paclitaxel alone.

"The key issue of this application is whether the significant improvement in progression-free survival, in the absence of an improvement in overall survival, is a measure of direct clinical benefit that supports regular approval of bevacizumab plus paclitaxel for first-line treatment of patients with metastatic breast cancer," the FDA reviewers stated in their executive summary.

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