ARTICLE | Regulation

Avastin Lessons

Lessons from Genentech's Avastin setback in metastatic breast cancer

July 26, 2010 7:00 AM UTC

The outcome of last week's FDA panel meeting to discuss Genentech Inc.'s Avastin bevacizumab illustrates exactly how the accelerated approval process was meant to work: to provide patients with few or no treatment options with early access to a drug that appears beneficial while further studies are run to validate the initial efficacy signal.

The panel also provided a clear reminder that companies winning accelerated approval must be ready with additional evidence to substantiate clinical benefit...