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The Food and Drug Administration and Genentech Inc. have announced "accelerated approval" of bevacizumab in combination with paclitaxel for treating patients who have not received chemotherapy for metastatic HER2-negative breast cancer.
The surprise decision came less than 3 months after an FDA advisory panel narrowly recommended against approval despite evidence that the anti-angiogenesis agent delays progression of the disease.
Bevacizumab, marketed as Avastin by Genentech, is a therapeutic antibody that binds to and inhibits human vascular endothelial growth factor, a protein thought to play an important role in angiogenesis and in maintaining existing blood vessels throughout a tumor's life cycle. It was previously approved as a treatment for lung cancer and for colon and rectal cancer.
