Revumenib receives FDA approval for adult and pediatric patients aged ≥1 year with R/R acute leukemia and a KMT2A translocation

The rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) was 21.2% (95% confidence interval [CI], 13.8–30.3), with a median duration of 6.4 months (95% CI, 2.7, not estimable). 

Among the 22 patients who achieved CR or CRh, the median time to reach CR/CRh was 1.9 months (range, 0.9–5.6 months). 

Out of 83 patients who required red blood cell (RBC) and/or platelet transfusions at the baseline, 12 became transfusion free during any 56-day post-baseline period.  

Of the 21 patients independent of both RBC and platelet transfusions at baseline, 10 remained transfusion free during any 56-day post-baseline period. 

The most common adverse reactions (≥20%) were hemorrhage, nausea, increased phosphate, musculoskeletal pain, infection, increased aspartate aminotransferase, febrile neutropenia, increased alanine aminotransferase, increased intact parathyroid hormone, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, decreased phosphate, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, viral infection, fatigue, and increased alkaline phosphatase.