USA – Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure

What is the purpose of the Surrogate Endpoint Table?

FDA’s surrogate endpoint table provides valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs. This table also fulfills a 21st Century Cures Act requirement to publish a list of “surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or a biological product” under both accelerated and traditional approval pathways.

Section 3011 of the 21st Century Cures Act established section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandates that the FDA publish a list of “surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product” under both accelerated and traditional approval provisions. The Surrogate Endpoint Table below fulfils this legislative requirement and is intended to provide valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs.

According to section 507(e)(9) of the FD&C Act “[t]he term ‘surrogate endpoint’ means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—

‘‘(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or

‘‘(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 506(c).’’

This surrogate endpoint table includes surrogate endpoints that sponsors have used as primary efficacy clinical trial endpoints for approval of new drug applications (NDAs) or biologics license applications (BLAs).  The table also includes surrogate endpoints that may be appropriate for use as a primary efficacy clinical trial endpoint for drug or biologic approval, although they have not yet been used to support an approved NDA or BLA. We believe that this list should facilitate consideration of potential surrogate endpoints when developers are designing their drug development programs…