OnCo
drugsProductApproved2024

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.

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Revumenib
PubChem
Mechanism, step by step
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1.Revumenib binds menin in the nucleus

Modality
Small-molecule menin inhibitor
Mechanism
Disrupts menin-KMT2A interaction, releasing differentiation block.
Brand / code
Revuforj
Dosing & schedule
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.

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.

Not appraisedSearch NICE
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.

Regulatory

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  1. Dec 2022DesignationUS

    Breakthrough Therapy designation source

  2. 15 Nov 2024ApprovalUS

    Relapsed/refractory KMT2A-rearranged acute leukaemia, age ≥1: first menin inhibitor source

  3. Oct 2025ApprovalUS

    Relapsed/refractory NPM1-mutant AML source

Approvals

RegionYearIndication
US2024Relapsed/refractory KMT2A-rearranged acute leukaemia, age ≥1
US2025Relapsed/refractory NPM1-mutant AML

Safety

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Toxicity profile
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.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part D (oral); commercial plans per formulary, often with prior authorisation

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
14 studies7 recruiting12 Phase 23 Phase 3
Search “Revumenib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Revumenib
intervention: Revumenib
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Literature trend49 papers in the last 12 months+53% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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