In all the trials completed for Avastin in the metastatic breast cancer setting, no evidence of increased overall survival was shown. For that reason, BCA commends the FDA's December 16th recommendation that the drug not be used to treat breast cancer.
The recommendation is a preliminary step toward revoking the drug's approval for breast cancer. Swiss drugmaker Roche has 15 days to request a public meeting on the issue.
Breast Cancer Action believes that finding better treatments for metastatic breast cancer is critically important when developing new drugs. This is especially true for patients for whom all other treatment options have failed.
We must give patients meaningful new options in treatment and not false promises. Therefore, we strongly advocate that the FDA not approve drugs for the treatment of breast cancer unless they can be shown to 1) improve overall survival, and/or 2) improve quality of life, and/or 3) cost less than therapies already available.
Dr. Richard Pazdur, the FDA's chief of cancer drug review, said, "Given the number of serious and life-threatening side effects, the FDA does not believe there is a favorable risk-to-benefit ratio."
In 2007, BCA was the only breast cancer organization to actively oppose the use of Avastin for metastatic breast cancer patients because of its failure to improve overall survival or quality of life, its side effects and its high price tag. We applaud the FDA for recommending that Roche's request for full approval of Avastin for advanced breast cancer treatment be denied.
The interests of patients must come before the profits of companies manufacturing the treatments. We need to continue to demand better drugs for people with metastatic disease. We have a long way to go to end this epidemic but the FDA's decision to put patient needs before drug company profits is at least a step in the right direction.