The FDA issued draft guidance advising sponsors developing multiple myeloma therapies to use minimal residual disease (MRD) negativity as a key endpoint for accelerated approval pathways. The agency emphasized MRD’s value as an intermediate endpoint given advances that have pushed overall response rates for current therapies into saturation territory. FDA and expert commentary cited by BioSpace notes that MRD offers earlier assessment of treatment effect and correlates with long‑term outcomes, but regulators also stressed the remaining uncertainty — accelerated approvals based on MRD may require confirmatory data for full approval. The guidance reflects the agency’s evolving standards for oncology trials as therapies improve and clinical endpoints shift. Sponsor teams and trial designers will need to adapt protocols and biomarker strategies to incorporate standardized MRD assays and prespecified confirmatory pathways.