FDA posts briefing document indicating bevacizumab (Avastin®) not performing as hoped

July 16, 2010

In preparation for the upcoming Oncologic Drugs Advisory Committee (ODAC) meeting on July 20, the Food and Drug Administration (FDA) has posted background briefing materials on bevacizumab (Avastin®) on its website.

FDA is weighing the benefits and risks of using bevacizumab with chemotherapy for treating metastatic breast cancer, and requests advice from ODAC. Two phase III studies AVADO and RIBBON I failed to confirm the magnitude of improvement in progression-free survival (PFS) seen in the E2100 trial used for the basis of accelerated approval. There was a trend in both trials towards better overall survival in the placebo arms, versus the arms with bevacizumab.  In addition, women treated with bevacizumab experienced almost twice as many serious side effects.