The FDA revoked approval of the breast cancer indication for Avastin (bevacizumab; Genentech), ruling that the drug has not been proved to be safe and effective for that use. Bevacizumab remains on the market as approved for use for certain types of other cancers, including colon, kidney, lung, and brain (glioblastoma multiforme) cancer. Bevacizumab had received accelerated approval for the breast cancer indication in 2008; however, the FDA’s Oncologic Drugs Advisory Committee later recommended this approval be withdrawn. Bevacizumab’s manufacturer filed an appeal, and the FDA held a 2-day public hearing on the issue in June 2011. The FDA issued the decision to revoke the breast cancer indication for bevacizumab on November 18, 2011.
TOP - February 2012, Vol 5, No 1 published on February 28, 2012 in FDA Updates
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Last modified: July 22, 2021
