Revumenib

Revumenib
Clinical data
Trade names	Revuforj
Other names	SNDX-5613
AHFS/Drugs.com	revuforj
License data	US DailyMed: Revumenib;
Routes of; administration	By mouth
Drug class	Antineoplastic; menin inhibitor
ATC code	None;
Legal status
Legal status	US: ℞-only;
Identifiers
	IUPAC name 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	2169919-21-3; 2169919-22-4;
PubChem CID	132212657;
DrugBank	DB18515; DBSALT003460;
ChemSpider	95502909;
UNII	LZ0M43NNF2; 75HI05N8HS;
KEGG	D12728; D12729;
ChEMBL	ChEMBL4650827; ChEMBL4650278;
PDB ligand	OQ4 (PDBe, RCSB PDB);
Chemical and physical data
Formula	C32H47FN6O4S
Molar mass	630.82 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES 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=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]

Medical uses

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

Society and culture

Legal status

Revumenib was approved for medical use in the United States in November 2024.^[3]^[4]^[5]

Names

Revumenib is the international nonproprietary name.^[6]

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

References

^ ^a ^b ^c ^d ^e ^f "Revuforj- revumenib tablet, film coated". DailyMed. 19 November 2024. Retrieved 28 November 2024.
^ 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.
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ "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. This article incorporates text from this source, which is in the public domain.
^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
^ "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.
^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl:10665/363551.

External links

"Revumenib (Code C165776)". NCI Thesaurus.
"Revumenib citrate". NCI Drug Dictionary.
Clinical trial number NCT04065399 for "A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation (AUGMENT-101)" at ClinicalTrials.gov
Clinical trial number NCT05918913 for "Expanded Access Program for Revumenib" at ClinicalTrials.gov

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[Revuforj_FDA_label-1] ^ ^a ^b ^c ^d ^e ^f "Revuforj- revumenib tablet, film coated". DailyMed. 19 November 2024. Retrieved 28 November 2024.

[Hussain_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.

[FDA_PR_20241115-3] ^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ "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. This article incorporates text from this source, which is in the public domain.

[Novel_Drug_Approvals_for_2024-4] "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.

[5] "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.

[6] World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl:10665/363551.

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