November 18, 2011 — The US Food and Drug Administration (FDA) announced today that it is rescinding its approval of bevacizumab (Avastin, Genentech) for treating breast cancer because the drug has not proven itself to be safe and effective for that indication.
"This was a difficult decision," FDA Commissioner Margaret Hamburg, MD, said in a press 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. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life."
Some of the risks associated with bevacizumab are severe hypertension, bleeding and hemorrhaging, heart attack or heart failure, and perforations forming in body parts such as the nose, stomach, and intestines.
Bevacizumab remains an approved treatment for certain kinds of colon, lung, kidney, and brain cancer, the FDA noted.
More information about the FDA's decision is available on the agency's Web site.
"This was a difficult decision," FDA Commissioner Margaret Hamburg, MD, said in a press 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. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life."
Some of the risks associated with bevacizumab are severe hypertension, bleeding and hemorrhaging, heart attack or heart failure, and perforations forming in body parts such as the nose, stomach, and intestines.
Bevacizumab remains an approved treatment for certain kinds of colon, lung, kidney, and brain cancer, the FDA noted.
More information about the FDA's decision is available on the agency's Web site.
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