Minimal Residual Disease in Multiple Myeloma: A Pivotal Regulatory Milestone for Accelerated Approval

This white paper examines the FDA’s January 2026 draft guidance on using minimal residual disease (MRD) as a surrogate primary endpoint to support accelerated approval in multiple myeloma. It explores the scientific rationale, regulatory expectations, trial design considerations, and assay validation requirements sponsors must address when incorporating MRD negativity into clinical development programs. Practical recommendations are provided to help sponsors navigate evolving approval pathways and engage effectively with regulatory authorities.

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