July 27, 2011
Margaret Hamburg, MD Commissioner, Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
RE: Docket No. FDA-2010-N-0621, Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab
Dear Commissioner Hamburg: I am writing to urge you to follow the Oncologic Drugs Advisory Committee’s (ODAC) June 29, 2011 unanimous recommendation to revoke bevacizumab (Avastin) as a treatment for breast cancer. Breast Cancer Action believes that women deserve more effective, less toxic treatments for breast cancer, and Avastin is not that treatment.
The results of multiple clinical trials performed by Genentech, the drug’s manufacturer, have not shown that Avastin prolongs women’s lives or improves the quality of their lives. Instead, there are significant and potentially fatal side effects associated with the treatment, including gastrointestinal perforation, problems with wound healing, and serious and sometimes fatal bleeding. The risks simply do not outweigh the scant benefits.
The FDA must follow the science when making decisions about drugs that impact people’s health and safety. In the case of Avastin, the science is clear. No increase in overall survival and no improvement in quality of life adds up to a treatment that should no longer receive FDA approval. Please follow the ODAC’s recommendation to revoke approval for Avastin as a treatment for breast cancer.
Karuna R. Jaggar
Executive Director, Breast Cancer Action