An FDA advisory panel has recommended that bevacizumab (Avastin) no longer be approved for use in patients with 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.