The United States Food and Drug Administration's (FDA's) Oncology Drugs Advisory Committee (ODAC) has recommended against the approval of Genentech’s Avastin (bevacizumab) for the treatment of metastatic breast cancer.
ODAC is an advisory committee that makes recommendations to the FDA. The FDA tends to follow ODACs recommendations; however, it is able to make its own decisions. The FDA has until February 23, 2008 to make a formal decision on the application by Genentech for the additional approval of Avastin.
Avastin is a targeted agent against the vascular endothelial growth factor receptor (VEGF). It is already approved for the treatment of colon and lung cancer.
ODAC votes were nearly split down the middle, with a main dispute being the endpoints of the trial. Progression-free was used as the main end-point of the study; many committee members felt that overall survival should have been the primary end-point. There was no improvement in overall survival with the addition of Avastin to the treatment regimen.
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