10/09/2026
Biomarkers are critical to oncology drug development and the FDA's Biomarker Qualification Program (BQP) has the potential to make their use more consistent and efficient. But why have so few biomarkers been qualified? Friends of Cancer Research convened a multi-stakeholder working group to explore how the program can better deliver on that potential.
The BQP was designed to qualify a biomarker for a defined context of use, so it can be applied across multiple development programs, reducing duplicative evidence generation and supporting more efficient trials. However, more than a decade in only 12 of the 107 programs that entered the BQP have reached qualification (as of September 28, 2026).
The problem is not the value of biomarker qualification itself, but its limitations in how the current framework is designed and implemented, including:
▪️Uncertainty about how qualification determinations are applied
▪️A stage-based structure that does not fit how biomarker evidence actually develops
▪️Timelines that routinely run past program targets
▪️Limited incentives to invest in biomarkers that benefit the whole field.
Addressing these challenges does not require rethinking the purpose of qualification but modernizing how it is operationalized. Our white paper recommends more transparent, predictable processes, adequate resourcing, and a tiered, risk-based structure that lets sponsors earn regulatory recognition as evidence matures, rather than an all-or-nothing determination at the end. Near-term improvements can be advanced through FDA guidance or internal policy, while longer-term reforms may require Congress to act.
Read “Modernizing the FDA Biomarker Qualification Program: Strengthening Regulatory Clarity and Broadening Biomarker Use in Drug Development”: https://bit.ly/4u8ZdO8.
