New Therapy Approved for Relapsed Leukemia

The FDA has approved Revuforj® (revumenib) as the first menin inhibitor for relapsed or refractory acute leukemia with KMT2A translocation, applicable to patients aged one year and older. This breakthrough therapy demonstrated a 21% complete remission rate in the Phase 1/2 AUGMENT-101 trial, with median remission duration of 6.4 months and manageable safety outcomes. The approval provides a critical option for this aggressive leukemia subtype, marked by high relapse rates and poor survival outcomes.

Syndax plans a November U.S. launch for adult and pediatric doses, with expanded pediatric formulations expected in 2025.