Abstract
Improvements in multiple myeloma (MM) treatments have extended patient survival to a decade or more. Treatment response rates >90% have introduced new challenges for drug development, including a need for early endpoints with greater sensitivity. The FDA, based on data from two academic research groups and industry, evaluated minimal residual disease (MRD) negativity as an intermediate endpoint for progression-free and overall survival, culminating in a unanimous vote by the Oncology Drugs Advisory Committee in April 2024 supporting MRD-negative complete response as an early endpoint reasonably likely to predict clinical benefit in MM that may be used to support accelerated approval.
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