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Revuforj

revumenib
Menin Inhibitor FDA Approved 2024 Syndax Pharmaceuticals
1. Indications and Usage

Relapsed or refractory acute leukemia (acute myeloid leukemia or acute lymphoblastic leukemia or mixed-phenotype acute leukemia) with a KMT2A (MLL) translocation, as detected by an FDA-approved test, in adult and pediatric patients 1 year of age and older.

2. Dosage and Administration

Adults and pediatric (BSA ≥1.51 m²): 163 mg orally twice daily
Pediatric (BSA 0.76-1.50 m²): 113 mg twice daily
Pediatric (BSA 0.50-0.75 m²): 63 mg twice daily
Take with or without food at approximately the same times each day
Strong CYP3A4 inhibitors: Reduce dose per PI
QTc monitoring: ECG before start, weekly × 4 weeks, then before each cycle and as needed

3. Dosage Forms and Strengths

Capsules: 50 mg, 100 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Differentiation Syndrome: Reported in 16% (9% Grade 3+, including fatal cases). Can present with fever, dyspnea, hypotension, pulmonary infiltrates, weight gain, peripheral edema. Treat with dexamethasone 10 mg IV BID and hydroxyurea if leukocytosis. Interrupt revumenib until resolved.
  • QTc Prolongation: QTcF >500 ms in 11%, increase >60 ms in 14%. Monitor ECGs and electrolytes. Correct hypokalemia, hypomagnesemia, hypocalcemia before starting.
  • Infections: Serious infections in 28% (fatal 6%). Febrile neutropenia in 33%.
6. Adverse Reactions
Most Common Adverse Reactions

Febrile neutropenia (33%), hemorrhage (31%), nausea (30%), differentiation syndrome (16%), musculoskeletal pain (28%), QTc prolongation (25%), infection (28%), mucositis (22%), diarrhea (22%), edema (21%), rash (16%), headache (14%)

Febrile neutropenia
33%
Hemorrhage
31%
Nausea
30%
Musculoskeletal Pain
28%
Infection
28%
QTc prolongation
25%
Mucositis
22%
Diarrhea
22%
Edema
21%
Differentiation Syndrome
16%
7. Drug Interactions

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Revumenib is a selective inhibitor of the menin-KMT2A (menin-MLL) protein-protein interaction. In leukemias harboring KMT2A rearrangements, the fusion oncoprotein (MLL-fusion) requires binding to menin to drive aberrant gene expression (including HOXA9 and MEIS1) that maintains the leukemic state. By blocking the menin-MLL interaction, revumenib disrupts the oncogenic transcriptional program, restores normal hematopoietic differentiation, and induces leukemia cell death.

Pharmacokinetics

Tmax: 1-2 hours. Half-life: approximately 13 hours. Protein binding: ~92%. Metabolized primarily by CYP3A4. Steady-state by Day 5. Excreted in feces (63%) and urine (22%).

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Trials on ClinicalTrials.gov ↗ 📚 PubMed Clinical Trials ↗
FDA-Approved Tumor Types

Revuforj has FDA-approved indications across the following cancer types covered on PipelineEvidence:

Acute Myeloid Leukemia
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Revuforj. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.
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