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MRD in AML: FDA’s regulatory perspective
Cara Rabik, MD, PhD, FDA, Silver Spring, MD, discusses the regulatory perspective from the U.S. Food and Drug Administration (FDA) on the use of measurable residual disease (MRD) in acute myeloid leukemia (AML). Dr Rabik introduces the requirements for regulatory endpoints in clinical trials, considerations for the use of MRD as an endpoint, shares lessons from other hematologic malignancies, and explains why AML is challenging. This presentation took place at the 8th International Workshop on Acute Leukemias (iwAL) in Cambridge, MA.
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