Decelerated approval

After years of hints, complaints and informal discussion, FDA has explicitly asked its Oncologic Drugs Advisory Committee - and ODAC has agreed - to raise the hurdle cancer drugs will have to clear in order to receive accelerated approval.

The panel agreed with FDA that, except in rare circumstances, single-arm trials are not a sufficient basis for accelerated approval. ODAC also backed FDA's desire for two confirmatory trials to verify clinical benefit, instead of the single confirmatory study that has been customary...