Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry

Issue Date: January 21, 2026
Issued by: Oncology Center of Excellence
Topic(s):
Status: Draft

Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry

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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