In a news release, the FDA stated that Avastin "has not been shown to be safe and effective" for treating breast cancer, but that Avastin would stay on the market as an FDA-approved treatment for certain types of colon, lung, kidney, and brain cancer.
The FDA started the process of removing Avastin's breast cancer indication in 2010. Genentech, the drug company that makes Avastin, appealed, completed two more studies, and submitted more data to the FDA. But now, the FDA's decision is final.
Doctors will still have the option of using Avastin off-label to treat breast cancer, Lillie Shockney, RN, administrator of the Johns Hopkins Breast Center in Baltimore, told WebMD earlier this year. "Off-label" refers to drugs that are prescribed for uses not specifically approved by the FDA.
Women with breast cancer who were anticipating starting therapy with Avastin must reconnect with their medical oncologist to discuss the next steps, Shockney said.
"This was a difficult decision," FDA commissioner Margaret Hamburg, MD, MPH, said in an FDA news release. "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. But patients must have confidence that the drugs they take are both safe and effective for their intended use.
"After reviewing the available studies, it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks," Hamburg said. "Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life."
Avastin and Breast Cancer
In 2008, the FDA approved Avastin as a breast cancer treatment for some women. That approval, which was fast-tracked, was based on preliminary studies that found that the drug increased progression-free survival -- the time in which women's breast cancer did not worsen.
But in July 2010, an FDA advisory panel voted 12-1 to remove the breast cancer indication from the drug’s label because follow-up studies found no differences in overall survival. These studies also showed that progression-free survival improved by less than three months, and that there was a high rate of side effects.
The FDA reviewed additional data submitted by Genentech but stood by its decision. In a news release, Genentech stated that it was "disappointed" by the FDA's decision and plans another study to try to identify breast cancer patients who might benefit from Avastin.
WebMD Senior Health Editor Miranda Hitti contributed to this report.