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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 3 10
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 (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 predicted - sensitive Revumenib FDA approved Actionable In a Phase I trial (AUGMENT 101), Revuforj (revumenib) treatment demonstrated acceptable safety and resulted in a complete remission or complete remission with partial hematologic recovery (CR/CRh) rate of 30% (18/60) and median duration of response of 9.1 mo in adult and pediatric patients 1 year or older with acute leukemia harboring KMT2A rearrangements or NPM1 mutations, with a CR/CRh rate of 33% (15/46) and median time to CR/CRh of 2.0 mo in KMT2A rearranged patients (PMID: 36922593; NCT04065399). 36922593 detail...