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GUIDANCE DOCUMENT

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability November 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
Docket No. FDA-2022-D-0084
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

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).

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: Docket No. FDA-2022-D-0084.

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