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GUIDANCE DOCUMENT

Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval Draft Guidance for Industry January 2026

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2025-D-2616
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

This guidance provides recommendations to sponsors about using minimal residual disease (MRD) and complete response (CR) in multiple myeloma as primary endpoints in trials evaluating drug and biological products intended to treat patients with multiple myeloma (MM) to support approval under accelerated approval. For the purpose of this guidance, the MRD endpoint refers to MRD negativity rate as assessed in the bone marrow by either flow cytometry- or sequencing-based methods in patients who have achieved a CR. The definition of CR includes patients who achieved CR or stringent CR.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-2616.

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