Avastin fails to slow tumor growth compared to chemo alone, experts find
A Food and Drug Administration panel of experts voted 12-1 in favor of removing the drug's approval for use against breast cancer alongside chemotherapy.
The FDA is not required to follow the advice of its panel, though it often does.
The negative vote is the first major setback for a blockbuster cancer drug that has racked up approvals for a half dozen forms of the disease. Avastin is also approved for colon, lung, kidney and brain cancer. The panel's ruling only pertains to Avastin's use in breast cancer.
Roche scientists argued Tuesday that patients taking Avastin experienced improved quality of life as tumor growth and other symptoms are delayed — but panelists were not convinced.
"The study shows there's very little benefit to patients — with significant toxicity risks and no clear survival benefit," said Natalie Compagni Portis, the panel's patient representative.
A spokeswoman for Roche's Genentech unit said the company will continue discussions with the agency.