The FDA issued draft guidance recommending minimal residual disease (MRD) negativity as an intermediate endpoint for accelerated approval pathways in multiple myeloma, reflecting evolving standards in trial design and biomarker use. The agency suggested MRD could supplement or in some cases replace overall response metrics for early regulatory decisions. The guidance stems from changes in the disease landscape—higher response rates and longer survivals make traditional endpoints less sensitive for differentiating new therapies. FDA officials recommend sponsors consider MRD negativity rates alongside other clinical data when pursuing accelerated approval. Sponsors should prepare to integrate standardized MRD assays and consider confirmatory endpoints for full approval; the guidance signals a tighter evidentiary bar and a move toward biomarker‑driven regulatory strategies in hematologic oncology.