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Revumenib receives FDA approval for adult and pediatric patients with R/R NPM1-mutated AML
On October 24, 2025, the U.S. Food and Drug Administration (FDA) approved the menin inhibitor revumenib for the treatment of adult and pediatric patients aged ≥1 year with relapsed/refractory (R/R) NPM1-mutated (NPM1m) acute myeloid leukemia (AML).1
Revumenib was previously approved by the FDA for the treatment of adult and pediatric patients aged ≥1 year with R/R acute leukemia and a KMT2A translocation.1 The expanded approval is based on phase II results from the AUGMENT-101 trial (NCT04065399).1
The complete remission (CR) plus CR with partial hematologic recovery (CRh) rate in 65 patients with R/R NPM1m AML was 23% (95% confidence interval [CI], 14–35%).
The median time to CR or CRh was 2.8 months, and the median duration of CR or CRh was 4.5 months.
On September 18, 2025, the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2 were updated to include revumenib as a Category 2A recommended treatment for R/R NPM1m AML, based on the positive AUGMENT-101 data.1
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