ARTICLE | Regulation

FDA backs use of ctDNA in cancer drug development 

Agency outlines four major use cases for liquid biopsies in early-stage solid tumor studies, noting some are more advanced than others

May 4, 2022 1:44 AM UTC

FDA draft guidance issued Monday endorses ctDNA as a biomarker in drug development for early-stage, non-metastatic solid tumors, and lays out the agency’s thinking on its uses and limitations in four broad areas: patient selection based on molecular alteration, risk assessment based molecular residual disease, response measurement, and as an early endpoint for clinical trials.

“ctDNA as a biomarker has a number of potential regulatory and clinical uses in the early-stage setting that may assist and expedite drug development,” FDA wrote in the guidance...