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Supplemental new drug application for revumenib in relapsed/refractory NPM1-mutated AML granted priority review by the FDA
On June 24, 2025, the U.S. Food and Drug Administration (FDA) granted priority review to the supplemental new drug application (sNDA) for the treatment of revumenib in relapsed/refractory NPM1-mutated AML.1
Revumenib is an oral, first-in-class menin inhibitor, which was approved by the FDA in 2024 for the treatment of relapsed/refractory KMT2A-rearranged acute leukemia.1 The sNDA is supported by positive data from the pivotal AUGMENT-101 trial (NCT04065399), and has been assigned a Prescription Drug User Fee Act target action date of October 25, 2025.1
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