Posted by Michael Wonder on 05 Sep 2024
Breakthrough therapies approved based on surrogate endpoints often lack post-marketing requirements
4 September 2024 - The use of surrogate markers to support drug approvals without requiring postmarketing studies can “hinder accurate and informed decision-making by patients and clinicians,” according to a recent study published in JAMA.
Drugs granted breakthrough therapy designation can go on to receive accelerated approval or traditional approval; while the US FDA requires post-marketing studies for drugs granted accelerated approval, they are often not required for breakthrough drugs granted traditional approval, even when surrogate markers are used for primary outcomes.
