This white paper examines the FDA’s January 2026 draft guidance allowing minimal residual disease negativity in complete response to potentially support accelerated approval of new multiple myeloma therapies. MRD may serve as a surrogate for progression-free survival when trials meet strict evidentiary, statistical, timing, and assay-validation standards. This approach could shorten development timelines, differentiate therapies through deeper responses, and enable earlier commercialization. The paper outlines options for randomized, single-arm, sequential, or parallel trial designs and stresses prespecified assessments, validated testing methods, confirmatory evidence, and early FDA engagement.

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