FDA Panel Says No More Avastin in Breast Cancer

An FDA advisory panel has recommended that bevacizumab (Avastin) no longer be approved for use in patients with breast cancer. As a condition of its 2008 approval, manufacturer Roche was required to conduct follow-up studies to show its benefits when used along with standard chemotherapy. The FDA advisory panel said that the two subsequent studies did not show the same magnitude of improvement as a previous study, E2100, which demonstrated a 5.5 month difference in median progression-free survival (PFS). One study (AVADO) observed 0.82 month and 0.88 month differences in median PFS while another study (RIBBON-1) observed a 1.2 month difference in median PFS.  Patients also reported significant side effects such as high blood pressure and fatigue.

The panel also stated that one of the follow-up studies failed to prove that the benefits of bevacizumab plus docetaxel (Taxotere) outweighed the risk associated with treatment. The FDA is scheduled to issue a final decision on September 17, 2010.