FDA Provides Draft Guidance for Using ctDNA Biomarker in Clinical Trials

The FDA has released a draft guidance for cancer drug sponsors on the design of clinical trials that use circulating cell-free plasma-derived tumor DNA (ctDNA) as a biomarker.

Because ctDNA can be measured in the bloodstream, the biomarker can be used in the early stages of a clinical trial, including to detect a targetable alteration, to determine specific study populations, to reflect participant response to treatment and to determine early signs of efficacy, the agency said.

The agency draft guidance can be used to support marketing approvals of drugs and biological products for treating solid tumor malignancies in the early-stage setting, the agency said.

Comments on the draft are due by July 2. Read the draft guidance here: bit.ly/3vAA6sN.