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Ref Type
PMID
Authors
Title Revuforj (revumenib) FDA Drug Label
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218944
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Revumenib Revumenib 8 11
Drug Name Trade Name Synonyms Drug Classes Drug Description
Revumenib Revuforj SNDX5613|SNDX 5613|SNDX-5613 MEN1-KMT2A Inhibitor 8 Revuforj (revumenib) inhibits the interaction between Menin and KMT2A (MLL), potentially resulting in antitumor activity and decreased proliferation of tumor cells with KMT2A (MLL) rearrangements or NPM1 mutations (PMID: 36922593, PMID: 36922589). Revuforj (revumenib) is FDA-approved for use in adult and pediatric patients 1 year and older with relapsed or refractory acute leukemia harboring KMT2A translocation, and in adult and pediatric patients 1 year and older with relapsed or refractory acute myeloid leukemia harboring susceptible NPM1 mutations (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KMT2A rearrange acute leukemia sensitive Revumenib FDA approved Actionable In a Phase I/II trial (AUGMENT 101) that supported FDA approval, Revuforj (revumenib) treatment was well tolerated and resulted in a complete remission (CR) or CR with partial hematologic recovery (CR + CRh) rate of 22.8% (13/57, p=0.0036) and an overall response rate of 63.2% in adult and pediatric patients with relapsed/refractory acute leukemia harboring KMT2A rearrangements (PMID: 39121437; NCT04065399). 39121437 detail...