{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T07:54:21Z","timestamp":1790927661598,"version":"4.1.0"},"reference-count":0,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"},{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acta Haematol"],"abstract":"<jats:p>Background Revumenib is a first-in-class oral inhibitor of the menin\u2013KMT2A protein\u2013protein interaction, approved by the United States Food and Drug Administration in November 2024 for relapsed or refractory acute leukemia with a KMT2A translocation and in October 2025 for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation. The registrational programme identified differentiation syndrome (and QTc-interval prolongation as adverse events of special interest. The post-marketing adverse-event experience has not been systematically characterized. Methods A retrospective disproportionality analysis of the FDA Adverse Event Reporting System (FAERS, 14,104,743 reports) was performed, restricted to reports in which revumenib was named as a primary or secondary suspect product (n = 283). Frequentist (proportional reporting ratio with Pearson \u03c7\u00b2; reporting odds ratio with 95% confidence interval) and Bayesian (information component with lower 2.5% bound; empirical Bayes geometric mean with lower 5% bound) metrics were calculated for every adverse event reported in association with the drug. A signal required more than three reports together with concurrent fulfilment of all four disproportionality criteria. Results Twenty-eight adverse events were evaluated; nineteen met the signal definition. Differentiation syndrome produced the strongest disproportionality (EBGM 15.38, EBGM\u2080\u2085 9.17). Cytopenias of every lineage, electrocardiogram QT prolonged (EBGM\u2080\u2085 3.67), and lower-magnitude constitutional and gastrointestinal events were also signalled. Nine events did not constitute signals, principally because of the case-count threshold. Conclusion Post-marketing reporting corroborates the safety profile established in AUGMENT-101 and identifies no novel toxicity category.<\/jats:p>","DOI":"10.1159\/aha\/abkag014","type":"journal-article","created":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T11:34:18Z","timestamp":1790508858000},"source":"Crossref","is-referenced-by-count":0,"title":["Post-Marketing Safety of the Menin Inhibitor Revumenib: A Bayesian Disproportionality Analysis of a National Database"],"prefix":"10.1159","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4080-3030","authenticated-orcid":false,"given":"Connor","family":"Frey","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2026,9,30]]},"container-title":["Acta Haematologica"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/article-pdf\/doi\/10.1159\/aha\/abkag014","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T07:17:21Z","timestamp":1790925441000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/aha\/abkag014"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,30]]},"references-count":0,"URL":"https:\/\/doi.org\/10.1159\/aha\/abkag014","archive":["Portico"],"relation":{},"ISSN":["0001-5792","1421-9662"],"issn-type":[{"value":"0001-5792","type":"print"},{"value":"1421-9662","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,30]]}}}