The FDA’s Biomarker Qualification Program (BQP) has had limited impact in qualifying new biomarkers over its eight years of operation, according to a new analysis from Friends of Cancer Research (Friends) published in Therapeutic Innovation & Regulatory Science. While the BQP created a framework for biomarker development, we believe targeted resources, stronger collaboration, and more timely engagement may be necessary for the program to fulfill its intended purpose.
The BQP was formalized in 2016 under the 21st Century Cures Act to provide a transparent and structured approach for stakeholders developing and qualifying novel biomarkers, including surrogate endpoints, for use in drug development. Surrogate endpoints are particularly important for enabling faster access to promising treatments through the Accelerated Approval pathway, especially for patients with serious illnesses.
Our key findings show that 61 biomarker projects have been accepted into the BQP, but only eight biomarkers have achieved full qualification. In addition, four applications have been withdrawn or rescinded following initial acceptance. Notably, none of the qualified biomarkers are surrogate endpoints. While five surrogate endpoint projects have entered the program, they have longer qualification plan development timelines compared to other biomarker categories, underscoring the challenges of qualifying these complex biomarkers despite their importance for accelerating treatment evaluations.
“Our analysis shows that while the Biomarker Qualification Program created a valuable framework, there may be targeted improvements to the program to fully realize its potential for novel response biomarkers.” Grace Collins, Manager of Regulatory & Data Insights at Friends.
With Prescription Drug User Fee Act (PDUFA) reauthorization discussions underway, this is a timely opportunity to strengthen and better resource the BQP. Targeted improvements could help ensure the program delivers on its promise to support development of novel biomarkers that can accelerate access to treatments for patients.
Read the publication: https://link.springer.com/article/10.1007/s43441-025-00889-6
Manuscript Authors
Grace Collins, Jeff D. Allen, Hillary S. Andrews, Bernat Navarro-Serer, Mark D. Stewart.