Therapeutic efficacy of Revumenib

The expansion of the indications for revumenib is based on the efficacy data of patients with relapsed/refractory NPM1-mutated acute myeloid leukemia in the phase Ⅱ segment of the pivotal clinical trial AUGMENT-101.

The complete remission (CR) plus complete remission with partial hematologic recovery (CRh) rate was 23% (15 out of 65 patients achieved remission; 95% confidence interval: 14%~35%).

The median time to achieve CR or CRh was 2.8 months, and the median duration of CR or CRh was 4.5 months.

The research results of the AUGMENT-101 trial have been published in the journal Blood and presented at the 2025 European Hematology Association (EHA) Annual Congress.

Dr. Joshua F. Zeidner, Director of Leukemia Research at the Lineberger Comprehensive Cancer Center of the University of North Carolina, stated: "The approval by the U.S. Food and Drug Administration (FDA) for the expanded indication of revumenib represents a major advance in the field of acute leukemia treatment.

It is the first targeted oral therapy approved for relapsed/refractory NPM1-mutated acute myeloid leukemia and relapsed/refractory KMT2A-rearranged acute leukemia, and this therapy has good tolerability and definite efficacy.

The significant clinical activity demonstrated by revumenib in clinical trials and clinical practice has established a brand-new treatment standard for these two aggressive and difficult-to-treat hematological malignancies."

FDA，2025.10