FDA Issues Draft Guidance for Industry on Using MRD and CR as Primary Endpoints in Multiple Myeloma Drug Trials to Support Accelerated Approval

On January 20, 2026, the Food and Drug Administration issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease (MRD) and complete response (CR) as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations.