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."