Researchers presenting at the American Society of Hematology reported pooled prospective data indicating that minimal residual disease (MRD)‑negative status before consolidation treatment correlates with longer overall survival in acute myeloid leukemia (AML). The dataset, described by Jesse Tettero of Virginia Tech’s Fralin Biomedical Research Institute, is the largest prospective pooled MRD analysis in AML to date and supports MRD’s potential role as an intermediate regulatory endpoint. Speakers noted precedents: MRD has long been an accepted surrogate in acute lymphoblastic leukemia and multiple myeloma and has already supported accelerated approvals in other hematologic indications. The presenters argued that MRD could enable faster demonstration of benefit for AML therapies under accelerated approval pathways. Clarification: a surrogate endpoint is a biomarker reasonably likely to predict clinical benefit and can shorten development timelines under accelerated regulatory pathways, but full approval typically still requires confirmatory outcome data such as overall survival.
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