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as reasonably likely to predict benefit on long-term outcomes in early-stage, solid tumor trials, agency says in new draft guidance.
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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.
Companies often do not focus on biomarker development and validation until too late in the game, FDA officials said at a recent Duke-Margolis meeting; experts cited the need for precompetitive work and public-private collaborations with an emphasis on early engagement, data sharing and transparency.
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.