Source: US Food and Drug Administration (FDA)

The US FDA has revoked it’s prior approval of Avastin for the treatment of metastatic breast cancer.  Avastin came onto the market as being a meidication with great promise for the treatment of metastatic breast cancer.  FDA Commissioner Margaret Hamburg stated plainly in her Decision of the Commissioner, that, “[T]there is no benefit to breast cancer patients that would justify its risks.”  Among Avastin’s more significant side effects are:  heart attack; heart failure; and, severe bleeding.

Avastin was orginally granted “Accelerated Approval” by the FDA in 2008.  Accelerated approval is an FDA process which “fast-tracks” drugs which might treat life-threatening conditions where evidence suggests that following more testing the drug’s effectiveness will be proven.  However, in this case, a different approval measure was used, Progression Free Survival (PFS) or demonstrating that patients survive longer while taking the drug.  Avastin’s sponsor, Genetech, Inc. had produced one study which suggested that the PFS was a median of 5.5 months.  However when the date for this single study was later produced, the 5.5 month survival was not supported and the dangers of the drug were found to outweigh the benefits.  Genetech was unable to provide any additional studies which suggested that Avastin had a clear clinical benefit for women with breast cancer.

Obviously disappointed with the decision, Genentech put out the following statement, “We are disappointed with this outcome.”   Yes there was more.  But don’t feel too badly for Big Pharma, Avastin will remain on the market despite the known risks of the drug.  The FDA has approved Avastin for the treatment of certain types of brain, colon, kidney and lung cancers and doctors are still free to prescribe Avastin for any use they see fit, including breast cancer (so-called “off label” usage).

Posted by: David M. Schwadron, Esquire