ctDNA Can Be Used For Patient Selection and Enrichment, But Not As Early Efficacy Endpoint, US FDA Says

Circulating tumor DNA (ctDNA) can be used as a biomarker in early-stage solid tumor clinical trials for purposes of patient selection, patient enrichment and as a measure of response. However, further data are needed to support use as an endpoint reasonably likely to predict long-term outcome, the US Food and Drug Administration said.

In a new draft guidance, the agency provides recommendations on uses of ctDNA as a biomarker in the early-stage setting, where the intent is curative