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Revumenib
Clinical data
Pronunciation/rษชหˆvuหmษ›nษชb/
rih-VOO-meh-nib
Trade namesRevuforj
Other namesSNDX-5613
AHFS/Drugs.comMonograph
MedlinePlusa624077
License data
Routes of
administration		By mouth
Drug classAntineoplastic; menin inhibitor
ATC code
Legal status
Legal status
Identifiers
  • N-ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro-N-propan-2-ylbenzamide
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
Chemical and physical data
FormulaC32H47FN6O4S
Molar mass630.82ย gยทmolโˆ’1
3D model (JSmol)
  • CCN(C(C)C)C(=O)C1=C(C=CC(=C1)F)OC2=CN=CN=C2N3CC4(C3)CCN(CC4)CC5CCC(CC5)NS(=O)(=O)CC
  • InChI=InChI=1S/C32H47FN6O4S/c1-5-39(23(3)4)31(40)27-17-25(33)9-12-28(27)43-29-18-34-22-35-30(29)38-20-32(21-38)13-15-37(16-14-32)19-24-7-10-26(11-8-24)36-44(41,42)6-2/h9,12,17-18,22-24,26,36H,5-8,10-11,13-16,19-21H2,1-4H3
  • Key:FRVSRBKUQZKTOW-UHFFFAOYSA-N
  • Key:AXNUWYROYVRYIM-OQIJCFCCSA-N

Revumenib, sold under the brand name Revuforj, is an anti-cancer medication used for the treatment of acute leukemias harboring lysine methyltransferase 2A gene (KMT2A) rearrangements.[1] It is designed to disrupt the interaction between menin and KMT2A (also known as MLL), which plays a role in the pathogenesis of these leukemias.[2] It is taken by mouth.[1]

The most common adverse reactions include hemorrhage, nausea, increased phosphate, musculoskeletal pain, infection, increased aspartate aminotransferase, febrile neutropenia, increased alanine aminotransferase, increased intact parathyroid hormone, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, decreased phosphate, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, viral infection, fatigue, and increased alkaline phosphatase.[3]

Revumenib was approved for medical use in the United States in November 2024.[1][3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[4]

Medical uses

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Revumenib is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation.[1][3]

In October 2025, the indication for revumenib was expanded for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in people who have no satisfactory alternative treatment options.[5]

Adverse effects

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The US prescribing information includes warnings and precautions for differentiation syndrome, QTc interval prolongation, Torsades de Pointes, and embryo-fetal toxicity.[5]

The most common adverse reactions include hemorrhage, nausea, increased phosphate, musculoskeletal pain, infection, increased aspartate aminotransferase, febrile neutropenia, increased alanine aminotransferase, increased intact parathyroid hormone, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, decreased phosphate, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, viral infection, fatigue, and increased alkaline phosphatase.[3]

History

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Efficacy was evaluated in a single-arm cohort of an open-label, multicenter trial (SNDX-5613-0700, NCT04065399; AUGMENT-101) in 104 adult and pediatric participants (at least 30 days old) with relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene translocation.[3] Participants with an 11q23 partial tandem duplication were excluded.[3] Revumenib was administered until disease progression, unacceptable toxicity, failure to achieve morphological leukemia-free state by four cycles of treatment, or hematopoietic stem cell transplantation.[3]

The US Food and Drug Administration (FDA) granted the application for revumenib priority review, breakthrough therapy, and orphan drug designations.[3]

Efficacy was evaluated in a single-arm cohort of an open-label, multi-center trial (SNDX-5613-0700, NCT04065399; AUGMENT-101).[5] A susceptible mutation was confirmed in enrolled participants using next generation sequencing or polymerase chain reaction of the last exon of NPM1.[5]

Society and culture

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Revumenib was approved for medical use in the United States in November 2024.[3][6][7]

Names

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Revumenib is the international nonproprietary name.[8]

It is sold under the brand name Revuforj.[1][3]

References

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  1. ^ a b c d e f "Revuforj- revumenib tablet, film coated". DailyMed. 19 November 2024. Retrieved 28 November 2024.
  2. ^ Hussain H, Zaidi SM, Hasan SM, Jahan AS, Rangwala BS, Rangwala HS, etย al. (May 2024). "Revumenib (SNDX-5613): a promising menin inhibitor for the management of relapsed and refractory acute myeloid leukaemia (AML)". Annals of Medicine and Surgery (2012). 86 (5): 2379โ€“2381. doi:10.1097/MS9.0000000000001888. PMCย 11060303. PMIDย 38694289.
  3. ^ a b c d e f g h i j "FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation". U.S. Food and Drug Administration (FDA) (Press release). 15 November 2024. Archived from the original on 20 November 2024. Retrieved 20 November 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  5. ^ a b c d "FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation". U.S. Food and Drug Administration (FDA). 24 October 2025. Retrieved 1 November 2025. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 19 April 2024. Retrieved 29 November 2024.
  7. ^ "Syndax Announces FDA Approval of Revuforj (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation" (Press release). Syndax Pharmaceuticals. 15 November 2024. Retrieved 20 November 2024 โ€“ via PR Newswire.
  8. ^ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). 2022. hdl:10665/363551.

Further reading

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๐Ÿ“š Artikel Terkait di Wikipedia

Acute myeloid leukemia

Gilteritinib Quizartinib Ivosidenib Olutasidenib Enasidenib Venetoclax Glasdegib Revumenib Ziftomenib Stem cell transplantation from a donor, called allogenic stem

Elranatamab

Copanlisib Duvelisib Idelalisib Inavolisib Parsaclisib Menin inhibitors Revumenib Ziftomenib Fibroblast growth factor receptor (FGFR) inhibitors Erdafitinib

Bleximenib

for similar indications. The most advanced compound in this class is revumenib (SNDX-5613), which received FDA approval in November 2024 after demonstrating

ATC code L01

Pelabresib L01XX85 Idroxioleic acid L01XX86 Calaspargase pegol L01XX87 Revumenib QL01XX91 Tigilanol tiglate QL01XX92 Verdinexor L01XY01 Cytarabine and

List of drugs granted breakthrough therapy designation

to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) Revumenib Treatment of relapsed or refractory acute leukemia with a lysine methyltransferase

List of drugs: Re

(INN) Revitropin revizinone (INN) Revolution revospirone (INN) Revuforj revumenib (INN) Rexomun Reyataz rezafungin (INN) rezatomidine (USAN, INN) Rezdiffra

Mosunetuzumab

Copanlisib Duvelisib Idelalisib Inavolisib Parsaclisib Menin inhibitors Revumenib Ziftomenib Fibroblast growth factor receptor (FGFR) inhibitors Erdafitinib

MEN1

effect by interfering with menin's interactions include the approved drug revumenib and the experimental drugs enzomenib, icovamenib, and ziftomenib. MEN1