Ziftomenib
Ziftomenib is the second menin inhibitor for leukaemia, approved in November 2025 as a once-daily pill for relapsed NPM1-mutated AML.
KOMET-001 (n=112 relapsed/refractory NPM1-mutated AML): CR 23%, ORR 33%, median OS 6.6 months. Approved 13 November 2025 (Kura Oncology / Kyowa Kirin). KOMET-007 combines ziftomenib with 7+3 and with venetoclax-azacitidine in newly diagnosed NPM1-mutated and KMT2A-rearranged AML, with high remission rates in early cohorts; KOMET-017 phase 3 registration studies are underway. Menin inhibition also being tested in KMT2Ar ALL.
1.Menin scaffolds KMT2A (or its fusion) onto chromatin at HOX loci
- Route
- Oral
- Schedule
- 600 mg once daily until progression
- Monitoring
- Differentiation syndrome (boxed warning), QT, counts
Source: www.fda.gov/drugs/resources-information-approved-drugs. Doses are for orientation; the current label governs.
- 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: ziftomenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 13 Nov 2025ApprovalUS
KOMET-001; priority review source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Relapsed/refractory NPM1-mutated AML with no satisfactory alternative |
| Adverse event |
|---|
| Differentiation syndrome Boxed warning; mitigated by early steroids and hydroxyurea |
| Nausea, diarrhoea Common, mostly low grade |
| Cytopenias Common in relapsed AML |
Rates read from the source. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Ziftomenib" OR ABSTRACT:"Ziftomenib" OR TITLE:"Komzifti" OR ABSTRACT:"Komzifti") 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 Ziftomenib, not a curated reading list.