Pregnancy Bliss | Reproductive Health Answers
Published: Friday, November 18, 2011 - 18:19
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.