FDA approval of an ovarian cancer claim for Genentech Inc.’s Avastin (bevacizumab) may help clarify the U.S. regulatory pathway for other sponsors in this disease setting based on a progression-free survival endpoint.
On Nov
Avastin Ovarian Cancer Approval Brings Some Clarity On PFS Endpoint
New claim for platinum-resistant recurrent disease based on a median 3.4-month improvement in progression-free survival – with favorable trends in overall survival, overall response rate and duration of response – confirms agency’s willingness to entertain a progression endpoint in this tumor type.