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Review
. 2025 Apr;85(4):577-583.
doi: 10.1007/s40265-025-02161-5.

Revumenib: First Approval

Yahiya Y Syed  1
Affiliations
Review

Revumenib: First Approval

Yahiya Y Syed. Drugs. 2025 Apr.

Abstract

Revumenib (Revuforj®) is an oral, first-in-class menin inhibitor developed by Syndax Pharmaceuticals for the treatment of KMT2A-rearranged (KMT2Ar) acute leukaemia, NPM1-mutated (NPM1m) acute myeloid leukaemia (AML) and solid tumours. The interaction between menin and the KMT2A protein complex leads to aberrant gene expression, driving leukaemogenic transcription. By blocking this interaction, revumenib promotes differentiation and exerts antileukaemic activity in KMT2Ar acute leukaemias and other menin inhibition-sensitive leukaemias. Revumenib received its first approval on 15 November 2024 in the USA for the treatment of relapsed or refractory (R/R) acute leukaemia with a KMT2A translocation in adult and paediatric patients 1 year and older. This article summarizes the milestones in the development of revumenib leading to this first approval.

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Conflict of interest statement

Declarations. Funding: The preparation of this review was not supported by any external funding. Authorship and Conflict of Interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Yahiya Y. Syed is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content. Ethics Approval, Consent to Participate, Consent to Publish, Availability of Data and Material, Code Availability: Not applicable.

References

    1. Issa GC, Ravandi F, DiNardo CD, et al. Therapeutic implications of menin inhibition in acute leukemias. Leukemia. 2021;35(9):2482–95. - DOI - PubMed
    1. Issa GC, Zarka J, Sasaki K, et al. Predictors of outcomes in adults with acute myeloid leukemia and KMT2A rearrangements. Blood Cancer J. 2021;11(9):162. - DOI - PubMed - PMC
    1. Syndax Pharmaceuticals. REVUFORJ® (revumenib) tablets, for oral use: US prescribing information. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218944s000lbl.pdf . Accessed 6 Jan 2024.
    1. Syndax Pharmaceuticals. 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 [media release]. 15 Nov 2024. https://ir.syndax.com/ .
    1. Syndax Pharmaceuticals. Form 10-K for the fiscal year ended December 31, 2023. https://ir.syndax.com/annual-reports-and-proxies . Accessed 20 Jan 2025.

MeSH terms

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