The U.S. Food and Drug Administration today announced it will revoke the approval of Avastin for breast cancer, citing a lack of evidence that the benefits outweigh the risks.
Avastin was approved for metastatic breast cancer in February 2008 under the agency's accelerated approval program, which offers patients early access to promising drugs while confirmatory clinical trials are carried out.
"Unfortunately the additional studies failed to confirm Avastin's initial promise," FDA Commissioner Dr. Margaret Hamburg said today.
The additional studies, carried out by Avastin maker Genentech, found only a small effect on tumor growth and no evidence that patients lived longer than they would taking standard chemotherapy. Because the drug can cause severe high blood pressure, bleeding, heart failure and perforations in the nose, stomach and intestines, an FDA advisory panel in June recommended revoking its approval.