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Le revumenib (SNDX-5613), un inhibiteur de la ménine orale, est approuvé par la FDA (nov. 2024) pour les rechutes...

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

IDBMA-KMT2A-REARR-AML
TypePertinence thérapeutique
Étatreviewed 2026-05-03 | pending_clinical_signoff | actionability review required
MaladiesDIS-AML
SourcesSRC-ELN-AML-2022 SRC-NCCN-AML-2025

Faits relatifs à l ' action en justice

BiomarqueurBIO-KMT2A-REARRANGEMENT
VarianteKMT2A (MLL) rearrangement — any fusion partner (KMT2A-MLLT3/AF9, KMT2A-MLLT4/AF6, KMT2A-ELL, KMT2A-MLLT1/ENL, KMT2A-AF1Q, KMT2A-AFDN among others; detected by FISH, RNA-seq, or cytogenetics)
MaladieDIS-AML
Niveau ESCATIA
Combinaisons recommandéesrevumenib 163 mg PO BID (with strong CYP3A4 inhibitor: 95 mg BID) monotherapy — R/R KMT2A-rearranged AML post ≥2 prior lines, revumenib + venetoclax + azacitidine (investigational; phase II enrollment ongoing as of 2026)
Résumé des faitsRevumenib (SNDX-5613), an oral menin inhibitor, is FDA-approved (Nov 2024) for relapsed/refractory KMT2A-rearranged acute leukemia (AML and ALL). AUGMENT-101 (Issa et al. NEJM 2023; Erba et al. ASH 2023 update): KMT2A-rearranged R/R AML/ALL — ORR 23% (CR + CRh + CRi), complete remission with full recovery 18%; mOS 8.0 mo. FDA accelerated approval based on remission rate as surrogate endpoint. KMT2A rearrangement is present in ~10% of adult AML (more common in secondary/therapy-related AML and infant leukemia). Menin is an essential co-factor of KMT2A-fusion oncoproteins — revumenib disrupts menin-MLL interaction, restoring differentiation block. Combination strategies under evaluation: revumenib + venetoclax + azacitidine (phase II ongoing). ELN 2022 risk: KMT2A-rearranged AML classified as intermediate risk (specific partner-dependent — MLLT3 intermediate; others may be adverse).

Notes

ESCAT IA (accelerated approval; confirmatory phase III AUGMENT-101P ongoing). Drug-drug interaction caution: revumenib is a CYP3A4 substrate; strong CYP3A4 inhibitors (azoles) require dose reduction to 95 mg BID. QTc prolongation monitoring required (baseline ECG, potassium/magnesium correction). Differentiation syndrome risk (similar to ATRA in APL) — monitor for fever, hypotension, pulmonary infiltrates; prophylactic corticosteroids under evaluation. Bridge to alloHCT should be planned for all eligible patients achieving remission. NPM1-mutated AML is a separate FDA-approved indication for revumenib (same drug, different biomarker mechanism) — see BMA for NPM1 when created.

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Pertinence thérapeutique