The FDA released draft guidance outlining how measurable residual disease (MRD) negativity could support accelerated approval for multiple myeloma therapies. The agency’s document, described in a BioCentury report, specifies evidentiary expectations for sponsors using MRD as a near-term efficacy endpoint and clarifies when MRD might substitute for longer clinical outcomes. The guidance aims to give drug developers a clearer regulatory path for novel myeloma agents that produce deep molecular responses. Sponsors should expect detailed requirements on assay validation, longitudinal MRD assessment, and linking MRD dynamics to clinical benefit. The draft also flags the need for standardized MRD technologies and prespecified statistical plans. BioCentury notes industry players including J&J publicly welcomed the move, positioning the draft as a potential accelerator for next-generation myeloma drugs.