Cancer Drug Endpoints: ctDNA Promising But Presents Many Challenges, Experts Say
To validate change in circulating tumor DNA as an early endpoint predictive of longer-term outcomes, academia, industry and regulators must harmonize data collection for trials in early-stage disease, a Friends of Cancer Research white paper states.
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FDA Cancer Center’s New ‘Projects’ Focus On Early Endpoints; Asian American, Native Hawaiian Populations
Launched in 2023, Project Endpoint focuses on advancing understanding of early, novel endpoints, while Project ASIATICA aims to bring greater awareness of challenges and health disparities faced by Asian American, Native Hawaiian, and Other Pacific Islander patients with cancer.
Circulating tumor DNA needs to be prospectively incorporated into trials to assess whether it correlates with long-term outcomes. More standardization in assays and when the biomarker is measured would strengthen analyses of data across studies, FDA officials said.
ctDNA Can Be Used For Patient Selection and Enrichment, But Not As Early Efficacy Endpoint, US FDA Says
More data are required to establish circulating tumor DNA, a blood biomarker, as reasonably likely to predict benefit on long-term outcomes in early-stage, solid tumor trials, agency says in new draft guidance.