SILVER SPRING, Md., Dec. 16, 2010 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration announced today that the agency
is recommending removing the breast cancer indication from the
label for Avastin (bevacizumab) because the drug has not been shown
to be safe and effective for that use.
The agency is making this recommendation after reviewing the
results of four clinical studies of Avastin in women with breast
cancer and determining that the data indicate that the drug does
not prolong overall survival in breast cancer patients or provide a
sufficient benefit in slowing disease progression to outweigh the
significant risk to patients. These risks include severe high blood
pressure; bleeding and hemorrhage; the development of perforations
(or “holes”) in the body, including in the nose, stomach, and
intestines; and heart attack or heart failure.
In July 2010, after reviewing all available data an independent
advisory committee, composed primarily of oncologists, voted 12-1
to remove the breast cancer indication from Avastin’s label.
“After careful review of the clinical data, we are recommending
that the breast cancer indication for Avastin be removed based on
evidence from four independent studies,” Janet Woodcock, M.D.,
director of the FDA’s Center for Drug Evaluation and Research.
“Subsequent studies failed to confirm the benefit observed in the
original trial. None of the studies demonstrated that patients
receiving Avastin lived longer and patients receiving Avastin
experienced a significant increase in serious side effects. The
limited effects of Avastin combined with the significant risks led
us to this difficult decision. The results of these studies are
disappointing. We encourage the company to conduct additional
research to identify if there may be select groups of patients who