Accelerated approval lets the FDA approve a drug for a serious condition based on a surrogate endpoint (a lab or imaging marker reasonably likely to predict clinical benefit) rather than waiting for a hard outcome like survival. In exchange, the company must run confirmatory trials to verify the benefit.
The trade-off
It gets important drugs to patients years earlier — but if the confirmatory trial fails, the FDA can withdraw the approval. That's a distinct, scheduled catalyst the market watches. Accelerated approval is one of several expedited pathways alongside priority review, Breakthrough Therapy, and Fast Track.
A lab value or imaging marker (e.g., tumor shrinkage) that is reasonably likely to predict real clinical benefit, used to support accelerated approval before long-term outcomes are known.
Can the FDA withdraw an accelerated approval?
Yes. If the required confirmatory trial fails to verify clinical benefit, the FDA can withdraw the approval.