The FDA’s draft guidance on using minimal residual disease (MRD) as a primary endpoint could create a new pathway for accelerated approval of novel multiple myeloma treatments. MRD negativity in complete response may serve as a surrogate endpoint for progression-free survival when supported by strong evidence and validated assays. This approach can enable earlier differentiation, faster development timelines, and more flexible trial designs, including single-trial and dual-trial models. Successful implementation requires defining MRD context of use, prespecifying endpoint timing and statistical plans, selecting and validating assay strategies, ensuring operational readiness, and engaging regulators early. Robust MRD execution and confirmatory trials will be critical to meeting accelerated

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