Regulators signaled support for measurable residual disease (MRD) and complete response as potential accelerated approval endpoints in multiple myeloma, publishing draft guidance and a related agency note. The FDA’s draft clarifies when MRD negativity may support accelerated approval and outlines trial design and assay expectations, aiming to shorten development timelines for therapies including cell and gene approaches. MRD (measurable residual disease) refers to ultra‑sensitive detection of cancer cells after treatment and is increasingly used as a surrogate in hematologic malignancies. The guidance sets conditions for assay validation, clinical correlation, and post‑marketing confirmatory studies; sponsors will need close agency engagement to use MRD in registrational pathways.