FDA and Avastin: Crossroads in an Era of Targeted Therapies
October 25, 2010
In early 2008, based on the results of its E2100 trial, which showed significant improvements in progression-free survival when combined with paclitaxel, Avastin (bevacizumab) gained an FDA accelerated approval. Median progression-free survival in the Avastin arm was 11.3 months compared with 5.8 months for paclitaxel alone (although overall survival in the two arms was similar). However, final approval would be dependent on subsequent trials showing similar degrees of benefit. When two additional trials were submitted for review, both showed significant improvements in progression-free survival, but again with no difference in overall survival. Subsequently, on July 20th of this year, the Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 not to recommend permanent approval of Avastin as first-line therapy in advanced breast cancer.