Revumenib
Revumenib (Revuforj) is the first menin inhibitor (2024), for acute leukaemias with KMT2A rearrangements or NPM1 mutations.
AUGMENT-101: CR/CRh ~23% in heavily pretreated KMT2A-rearranged leukaemia; NPM1-mutant AML approval 2025. Differentiation syndrome and QT prolongation. Syndax. Ziftomenib (Kura/Kyowa Kirin) approved 2025.
1.Revumenib binds menin in the nucleus
- Route
- Oral
- Schedule
- 270 mg twice daily (≥40 kg) or 160 mg BID with strong CYP3A4 inhibitors; weight-based below 40 kg
- Dose modifications
- Hold for QTc >500 ms or grade 3 differentiation syndrome; steroids for differentiation syndrome
- Monitoring
- ECG before and during treatment; electrolytes; signs of differentiation syndrome
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: revumenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Dec 2022DesignationUS
Breakthrough Therapy designation source
- 15 Nov 2024ApprovalUS
Relapsed/refractory KMT2A-rearranged acute leukaemia, age ≥1: first menin inhibitor source
- Oct 2025ApprovalUS
Relapsed/refractory NPM1-mutant AML source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- TrialKOMET-001
Shares NPM1 mutation, Ziftomenib, Menin, Acute myeloid leukaemia.
- TrialInterfant-06
Shares Menin inhibitors for infant KMT2A-rearranged ALL, KMT2A (MLL) rearrangement, Rare and paediatric cancers without markets, Acute lymphoblastic leukaemia.
- CompanyKura Oncology
Shares AUGMENT-101: revumenib, the first menin inhibitor, in relapsed leukaemias driven by KMT2A rearrangement or NPM1 mutation, Ziftomenib, Acute myeloid leukaemia.
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Shares Eunice S. Wang, Differentiation syndrome, Acute myeloid leukaemia.
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Shares Differentiation syndrome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.