AML MRD surrogate gains traction — could speed approvals by years

Data presented at ASH support measurable residual disease (MRD) as a surrogate endpoint in acute myeloid leukemia (AML), potentially enabling faster regulatory pathways. Researchers pooled 1,858 patients in analyses presented by Jesse Tettero and collaborators (Harmony Alliance) and showed MRD‑negative status correlates with longer overall survival and may predict treatment benefit. Investigators and sponsors argued that when validated as a surrogate, MRD could shorten development timelines by roughly four to five years, but adoption will require regulatory alignment on assay standards and timing.