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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.
Displaces KMT2A/KMT2A-fusion complexes from menin, silencing HOXA9/MEIS1 and releasing the differentiation block in NPM1-mutant and KMT2A-rearranged blasts. Connects to Menin, NPM1 mutation and KMT2A (MLL) rearrangement.
1.Menin scaffolds KMT2A (or its fusion) onto chromatin at HOX loci
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Sources: NICE search: ziftomenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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KOMET-001; priority review source
| 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.
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Query 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.
Shares Menin inhibitors for infant KMT2A-rearranged ALL, Differentiation syndrome, NPM1 mutation, AUGMENT-101: revumenib, the first menin inhibitor, in relapsed leukaemias driven by KMT2A rearrangement or NPM1 mutation.
Shares AUGMENT-101: revumenib, the first menin inhibitor, in relapsed leukaemias driven by KMT2A rearrangement or NPM1 mutation, Revumenib, Menin, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares AUGMENT-101: revumenib, the first menin inhibitor, in relapsed leukaemias driven by KMT2A rearrangement or NPM1 mutation, Revumenib, Menin, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares MEIS1, HOXA9, Menin / KMT2A (HOXA9-MEIS1 axis), Revumenib.
Shares Menin inhibitors for infant KMT2A-rearranged ALL, KMT2A (MLL) rearrangement, Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year), Acute lymphoblastic leukaemia.
Shares NPM1 mutation, KMT2A (MLL) rearrangement, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Acute myeloid leukaemia.
Shares NPM1 mutation, AUGMENT-101: revumenib, the first menin inhibitor, in relapsed leukaemias driven by KMT2A rearrangement or NPM1 mutation, myeloMATCH, Acute lymphoblastic leukaemia.
Shares Differentiation syndrome, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.