Today, the FDA’s Oncological Drug Advisory Panel (ODAC) unanimously voted to revoke Avastin as a treatment for breast cancer. They rejected a compromise proposal made by Genentech that the approval be retained while the company conducts another clinical trial to confirm that the drug works. Recent studies have not shown that the drug prolonged women’s lives or improved the quality of their lives.
The results of 5 clinical trials performed by Genentech show that Avastin does not prolong overall survival in breast cancer patients, or provide a sufficient benefit in slowing disease progression to outweigh the significant risks. Although some individual women believe that Avastin worked for them, there are many women who are not here to tell their story about how Avastin didn’t work.
Avastin received accelerated approval for metastatic breast cancer in 2008 under a program that allows drugs for serious diseases to reach the market more quickly, subject to further study. If we are to continue to speed up the rate at which treatments reach patients we must be able to take back approval when the evidence shows that a drug doesn’t work. We all want better treatment for women with this disease. Unfortunately, Avastin is not that treatment. Breast Cancer Action supports ODAC’s recommendation and will continue to demand and support the approval of effective, less toxic treatments options for all breast cancer.