FDA Lists Surrogate Endpoints for Drug Sponsors

The FDA on Wednesday published a list for drug sponsors of surrogate endpoints they may consider in trials to support drug approvals or licensures.

The list — the first released under the 21st Century Cures Act — includes surrogate endpoints sponsors previously used as NDA and BLA primary efficacy clinical trial endpoints as well as some that could potentially be used.

But the agency cautioned that “the acceptability of these surrogate endpoints for use in a particular drug or biologic development program will be determined on a case-by-case basis,” so sponsors should clear their plans with staff at CDER or CBER.