The FDA has granted a hearing to allow Genentech the opportunity to present its views on why Avastin (bevacizumab) should remain FDA-approved for metastatic breast cancer. In December 2010, the FDA announced its recommendation for the removal of the breast cancer indication from the labeling for Avastin after data from four clinical studies in women with breast cancer indicated that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.
The FDA has scheduled the hearing for June 28 and 29, 2011. Currently, and until the conclusion of the proceedings with the FDA, Avastin remains approved for use in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer. The hearing does not affect Avastin’s approval for use in colon, kidney, brain, and lung cancers.
Avastin is a biologic antibody designed to specifically bind to vascular endothelial growth factor (VEGF), a protein that plays an important role in angiogenesis. It interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells.
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