The Food and Drug Administration revoked the use of Avastin for breast cancer treatments Friday, saying that the Roche-owned drug was not safe or effective specifically to treat breast cancer.
The drug maintained its approval for other forms of cancer of the brain, colon, kidney and lung, federal officials said.
This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments, FDA Commissioner Margaret Hamburg, said Friday. But patients must have confidence that the drugs they take are both safe and effective for their intended use.
FDA officials said that Avastin didn't lead patients with breast cancer to live longer or have a higher quality of life.
On Friday, Hamburg released the 69-page decision delivered months after a two-day public hearing in June and thousands of pages of documents.
I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug, Hamburg said.
Genentech, now owned by Roche, originally developed the drug that received FDA approval for breast cancer treatments in 2008.
Stock prices in Roche Holding AG dropped 1 percent on the news to $38.75 per share by noon Friday EST.
Roche officials said they would not appeal the FDA's decision and instead will start a new phase III trial of Avastin in combination with the drug paclitaxel to treat metastasized breast cancer.
We are disappointed with the outcome, Hal Barron, chief medical officer at Roche, said in a statement. Despite today's action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin.