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    Minimal Residual Disease as a Surrogate Endpoint for Product Development for Multiple Myeloma: Comparing FDA and EMA Guidances

    This article discusses the need to update regulatory science to include the use of Minimal Residual Disease (MRD) as a specific measure of tumor burden for multiple myeloma at levels undetectable through conventional laboratory techniques. The authors suggest MRD can potentially be used as a clinical and regulatory endpoint to evaluate a drug’s effect both on patients’ risk of future relapse risk and subsequent treatment survival outcomes, thus serving as a surrogate endpo...