The FDA issued draft guidance updating preferred endpoints for multiple myeloma drug development, advocating minimal residual disease (MRD) negativity as an intermediate endpoint for accelerated approvals alongside or in place of overall response rate (ORR) in certain settings. The agency referenced prior advisory‑committee consensus on MRD and stressed that MRD may shorten timelines for getting promising therapies to patients under accelerated pathways. FDA and former agency leaders cautioned that MRD carries uncertainty and that full approvals will still likely require more conventional long‑term outcomes. The draft guidance reflects evolving measurement technology and changing patient trajectories as treatments improve response rates substantially. Sponsors should design registrational strategies that align MRD timing and assays with confirmatory endpoints, and regulators will expect robust assay standardization and clinical correlation to long‑term benefit.
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