In a letter to the Oncologic Drugs Advisory Committee (ODAC), BCA urged denial based on the fact that the drug's maker, biotech giant Genentech, did not provide data indicating that Avastin improved overall survival or quality of life.
By a 5-4 vote, the committee agreed, indicating that the toxic side effects outweighed the potential benefits of the drug. ODAC member and patient advocate Natalie Compagni Portis told the New York Times that she voted no because while it's painfully true that metastatic breast cancer isn't curable, "I don't think that means that we should just say, 'Well, here, try this,' if there isn't meaningful data to support it."
BCA Executive Director Barbara A. Brenner told the San Francisco Chronicle, "It's not necessarily a bad drug. We just don't know if it's a good drug." Brenner also criticized the estimated $100,000 a year price tag for Avastin.
BCA believes that a drug should increase overall survival or improve quality of life before being approved. Additionally, it should be more affordable than the available alternatives.The recommendation now goes to the FDA commissioner, who will make a decision in February. We will continue taking action--and asking you to do so--on the issue, so stay tuned.