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Revumenib (Revuforj) is the first menin inhibitor (2024), for acute leukaemias with KMT2A rearrangements or NPM1 mutations.
Revumenib is a small-molecule menin inhibitor that disrupts the menin-KMT2A interaction, releasing the differentiation block that keeps KMT2A-rearranged and NPM1-mutant leukaemia cells immature. It was approved in 2024, the first menin inhibitor, for relapsed or refractory KMT2A-rearranged acute leukaemia, on AUGMENT-101 (CR/CRh about 23% in heavily pretreated patients), and in 2025 for relapsed or refractory NPM1-mutant AML. Dosing is 270 mg twice daily for patients of 40 kg or more, reduced to 160 mg with strong CYP3A4 inhibitors. Differentiation syndrome and QT prolongation are the key risks. Syndax developed it and ziftomenib (Kura/Kyowa Kirin) was approved in 2025; acquired MEN1 mutations cause resistance, and front-line combinations with venetoclax and azacitidine are being tested. For a newcomer: a pill that makes leukaemia cells grow up instead of multiplying.
Disrupts menin-KMT2A interaction, releasing differentiation block. Connects to Menin.
1.Revumenib binds menin in the nucleus
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). FDA-approved November 2024 for KMT2A-rearranged acute leukaemia; NPM1-mutant AML added 2025.
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. KMT2A rearrangement or NPM1 mutation documented.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE search: revumenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Breakthrough Therapy designation source
Relapsed/refractory KMT2A-rearranged acute leukaemia, age ≥1: first menin inhibitor source
Relapsed/refractory NPM1-mutant AML source
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Relapsed/refractory KMT2A-rearranged acute leukaemia, age ≥1 |
| US | 2025 | Relapsed/refractory NPM1-mutant AML |
| Adverse event |
|---|
| Differentiation syndrome |
| QTc prolongation |
| Nausea |
| Febrile neutropenia |
| Haemorrhage |
| Infections |
AUGMENT-101: ~27% any grade; boxed warning. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Revumenib" OR ABSTRACT:"Revumenib" OR TITLE:"Revuforj" OR ABSTRACT:"Revuforj") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Revumenib, not a curated reading list.
Shares NPM1 mutation, Ziftomenib, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Menin.
Shares Eunice S. Wang, Differentiation syndrome, Acute myeloid leukaemia (KEGG map), Secondary and therapy-related acute myeloid leukaemia.
Shares NPM1 mutation, KMT2A (MLL) rearrangement, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Secondary and therapy-related acute myeloid leukaemia.
Shares Secondary and therapy-related acute myeloid leukaemia, Higher-risk myelodysplastic syndromes, Acute myeloid leukaemia in older or unfit patients, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares Menin inhibitors for infant KMT2A-rearranged ALL, KMT2A (MLL) rearrangement, Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year), Rare and paediatric cancers without markets.
Shares Menin inhibitor + venetoclax + azacitidine, Secondary and therapy-related acute myeloid leukaemia, Acute myeloid leukaemia in older or unfit patients, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares Secondary and therapy-related acute myeloid leukaemia, Higher-risk myelodysplastic syndromes, Acute myeloid leukaemia in older or unfit patients, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares Eunice S. Wang, Menin / KMT2A (HOXA9-MEIS1 axis), NPM1 mutation, Acute myeloid leukaemia (KEGG map).