Last reviewed 2026-04-20 · How we verify

Revuforj (REVUMENIB)

Revuforj works by inhibiting an enzyme that is involved in the growth and survival of cancer cells.

At a glance

Mechanism of action

Revumenib is a menin inhibitor that blocks the interaction of both wild-type lysine methyltransferase 2A (KMT2A) and KMT2A fusion proteins with menin. The binding of wild-type KMT2A or KMT2A fusion proteins with menin is involved in NPM1 mutated acute myeloid leukemias and KMT2A - rearranged acute leukemias, respectively, through activation of a leukemogenic transcriptional pathway. Susceptible NPM1 mutations are defined as those that result in loss of the nucleolar localization signal and the insertion of a new nuclear export signal leading to the accumulation of mutant NPM1 in the cytoplasm of AML cells. The most common of such NPM1 mutations in patients with AML are Types A, B, and D. In nonclinical studies using cells that express KMT2A fusions, inhibition of the menin-KMT2A interaction with revumenib altered the transcription of multiple genes including differentiation markers. In nonclinical in vitro and in vivo studies, revumenib demonstrated antiprolife

Approved indications

• relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation
• relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation

Boxed warnings

• WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION and TORSADES DE POINTES Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. [see Dosage and Administration (2.3 ) , Warnings and Precautions (5.1) , and Adverse Reactions (6.1) ] . QTc prolongation and Torsades de Pointes have occurred in patients receiving REVUFORJ. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate REVUFORJ in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue REVUFORJ. [see Dosage and Administration (2.3) , Warnings and Precautions (5.2) , and Adverse Reactions (6.1) ] WARNING: DIFFERENTIATION SYNDROME, and QTc PROLONGATION and TORSADES DE POINTES See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 2.3 , 5.1 ) QTc prolongation and Torsades de Pointes have occurred in patients receiving REVUFORJ. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate REVUFORJ in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue REVUFORJ. ( 2.3 , 5.2 ).

Common side effects

• Hemorrhage
• Nausea
• Infection without identified pathogen
• Bacterial infection
• Viral Infection
• Diarrhea
• Constipation
• Phosphate increased
• Aspartate aminotransferase increased
• Alanine aminotransferase increased
• Creatinine increased
• Musculoskeletal pain

Drug interactions

• Strong CYP3A4 Inhibitors
• Strong or Moderate CYP3A4 Inducers
• QTc Prolonging Drugs

Key clinical trials

• Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene (PHASE1)
• A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia (PHASE1)
• Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation (PHASE3)
• Revumenib in Combination With 7+3 + Midostaurin in AML (PHASE1)
• A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation (PHASE1,PHASE2)
• SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation (PHASE1)
• Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant (PHASE1)
• A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients (PHASE1)

Patents

Primary sources

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