FDA revokes approval on blockbuster breast cancer drug

Agency cites lack of evidence that benefits outweigh risks

The U.S. Food and Drug Administration announced on Friday it will revoke its approval of blockbuster drug Avastin for use in breast cancer patients, saying it found no evidence that it prolongs their lives, while it has serious side effects. The FDA had initially approved Avastin to treat metastatic breast cancer in 2008 under an expedited approval program that grants patients early access to promising drugs even as additional clinical trials are carried out. “Unfortunately the additional studies failed to confirm Avastin’s initial promise,” FDA Commissioner Dr. Margaret Hamburg told ABC News. The additional evidence showed that Avastin patients lived no longer than those taking standard chemotherapy. The drug, however, can cause serious conditions such as severe high blood pressure, as well as bleeding and perforations in the nose, stomach and intestines.

ABC News

Looking for more?

Get the best of Maclean's sent straight to your inbox. Sign up for news, commentary and analysis.