The FDA issued draft guidance advising sponsors to use minimal residual disease (MRD) negativity as an intermediate endpoint for accelerated approval of multiple myeloma therapies. The agency cited advances in disease assessment and changing patient journeys as the rationale for placing MRD at the center of early regulatory decisions. Regulators and industry experts note MRD is an earlier biomarker of deep remission than traditional overall response rate; sponsors will still face expectations for confirmatory data showing durability and clinical benefit to convert accelerated approvals to full approval.