The U.S. Food and Drug Administration released draft guidance outlining how measurable residual disease (MRD) negativity and complete response measures could support accelerated approval in multiple myeloma. The agency’s step formalizes an evidentiary route for sponsors to use sensitive molecular minimal‑residual disease assays as near‑term efficacy endpoints when traditional clinical endpoints would take years. BioCentury reported that the draft guidance describes evidentiary frameworks and caveats for MRD use in registrational pathways, including assay validation and longitudinal clinical correlation. The guidance is positioned as a potential accelerator for therapies that produce deep molecular responses but lack immediate hard clinical‑outcome readouts. Regulatory guidance of this type typically reshapes clinical trial design and investment priorities across oncology R&D; sponsors will need to align assay choice, statistical plans, and confirmatory study designs with the FDA’s recommendations. Source: BioCentury reporting and the FDA draft guidance text.