Issue Date: November 27, 2024
Issued by: Oncology Center of Excellence
Topic(s):
Status: Final
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability
This guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage (curative-intent) setting. This guidance reflects FDA’s current thinking regarding drug development and clinical trial design issues related to the use of ctDNA as a biomarker in clinical trials for solid tumor malignancies in the curative-intent setting. Standardization and harmonization of ctDNA assays and methodologies will also be discussed, with a particular focus on assay considerations to assess for molecular residual disease (MRD).
Download the Guidance Document
