REVUFORJ (revumenib citrate)
REVUFORJ is a medication used for adults and children at least one year old who have certain types of acute leukemia that have returned or did not respond to previous therapies. It helps patients with a specific genetic change called a KMT2A translocation or those with acute myeloid leukemia (AML) featuring a susceptible NPM1 mutation. This drug is typically prescribed for the NPM1-mutated form of the disease when other treatment options are no longer suitable.
How REVUFORJ Works
This drug works by blocking the interaction between a protein called menin and KMT2A proteins, which are involved in driving the growth of leukemia cells. By stopping these proteins from binding, the medication alters the activity of genes involved in cancer progression and encourages cell differentiation. This process helps stop the spread of leukemia cells and reduces tumor activity in the body.
Details
- Status
- Prescription
- First Approved
- 2024-11-15
- Patent Cliff
- 2042
- Routes
- ORAL
- Dosage Forms
- TABLET
REVUFORJ Approval History
What REVUFORJ Treats
2 indicationsREVUFORJ is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Leukemia
- Acute Myeloid Leukemia
REVUFORJ Boxed 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 (...
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 ).
REVUFORJ Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in REVUFORJ's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications REVUFORJ treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to REVUFORJ
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REVUFORJ FDA Label Details
Indications & Usage
FDA Label (PDF)REVUFORJ is indicated for the treatment of Acute Leukemia; Acute Myeloid Leukemia.
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...
REVUFORJ Patents & Exclusivity
Patents (3 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
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Patent Timeline
- • Cliff: 2042
- • 45 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 19 similar drugs
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.