Changing End Points in Breast-Cancer Drug Approval — The Avastin Story

Abstract

In December 2007, the Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration (FDA) met to discuss the risks and benefits of Genentech's Avastin (bevacizumab) for use in combination with paclitaxel for first-line treatment of locally recurrent or metastatic HER2-negative breast cancer. In an unusual move, Genentech and the FDA proposed that the committee (on which I serve as a voting consultant) consider progression-free survival rather than overall survival as the primary end point. In the key study submitted, bevacizumab plus paclitaxel was statistically superior to paclitaxel alone in terms of progression-free survival but not overall survival. Surprisingly, . . .