Should Genentech ’s cancer-fighting drug Avastin stay on the market for women with metastatic breast cancer?
When all is said and done, this decision comes down to statistics and rules, and as one speaker said Tuesday, the same rules that allow accelerated approval allow accelerated disapproval. The same FDA and the same Richard Pazdur allowed Avastin onto the market conditionally; they opened the door based on statistics that said women could benefit from Avastin.
They also can close that door, again based on cold, hard numbers, not emotion.
But what's the fallout on companies using the accelerated approval process in the future, and what's the impact on the FDA?