Reputation and Precedent in the Bevacizumab Decision

Abstract

In February 2008, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bevacizumab (Avastin) in combination with paclitaxel as first-line treatment for HER-2 negative metastatic breast cancer. Approval was based on the results of E2100, a cooperative-group randomized trial that showed a 5.5-month increase in progression-free survival associated with the addition of bevacizumab to paclitaxel therapy.(1),(2) Confirmatory studies by Genentech, the manufacturer, however, showed that bevacizumab's benefits for progression-free survival may be appreciably smaller than those shown in E2100 and have demonstrated convincingly that the addition of bevacizumab to the chemotherapy agents they have tested offers no . . .