Revumenib

Last updated

Revumenib
Revumenib.svg
Clinical data
Trade names Revuforj
Other namesSNDX-5613
AHFS/Drugs.com Monograph
MedlinePlus a624077
License data
Routes of
administration 		By mouth
Drug class Antineoplastic; menin inhibitor
ATC code
  • None
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
Formula C32H47FN6O4S
Molar mass 630.82 g·mol−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]

Contents

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

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

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

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

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

Names

Revumenib is the international nonproprietary name. [8]

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

References

  1. 1 2 3 4 5 6 "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, et 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): 2379–2381. doi:10.1097/MS9.0000000000001888. PMC   11060303 . PMID   38694289.
  3. 1 2 3 4 5 6 7 8 9 10 "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.PD-icon.svg 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. 1 2 3 4 "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.PD-icon.svg 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– via PR Newswire.
  8. ↑ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl: 10665/363551 .

Further reading

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