Revumenib
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
| ID | DRUG-REVUMENIB |
|---|---|
| Tipo | Fármaco |
| Aliaces | RevuforjРевуменіб |
| Situación | reviewed 2026-04-30 | pending_clinical_signoff |
| Enfermedades | DIS-AML |
| Fuentes | SRC-NCCN-AML-2025 |
Datos sobre drogas
| Clase | Inhibidor selectivo de la interacción de la menina-MLL (KMT2A) |
|---|---|
| Mecanismo | Small-molecule inhibitor of the menin-KMT2A (MLL) protein-protein interaction. KMT2A-rearranged and NPM1-mutated leukemias are dependent on menin recruitment to KMT2A-fusion or wild-type KMT2A complexes that drive aberrant HOXA / MEIS1 transcription. Disrupting menin-MLL displaces the leukemogenic transcriptional program, inducing differentiation and apoptosis of leukemic blasts. FDA-approved Nov 2024 on the basis of AUGMENT-101 phase 1/2 trial. |
| Dosificación típica | 163 mg PO q12h with strong CYP3A inhibitor (cobicistat) co-administration (label-required pharmacokinetic boost), OR 270 mg PO q12h without CYP3A inhibitor. Continuous, until disease progression or unacceptable toxicity. Take with or without food. AUGMENT-101 schedule. |
| Ucrania registrada | Falso |
| NSZU reembolsado | Falso |
| Ucrania verificada por última vez | 2026-04-30 |
Advertencias
- Síndrome de diferenciación: fatal si no se reconoce; corticoides + interrupción de la dosis obligatoria (~16% en AGOMENTO-101)
- Alargamiento del intervalo QTc: basal + ECG serial; K+ correcto ≥4,0 mEq/L y Mg++ ≥2,0 mg/dL
Notas
Pivotal trial: AUGMENT-101 (Issa et al., Nature 2024 / NEJM 2025) — phase 1/2 of revumenib monotherapy in R/R KMT2A-r and NPM1-mut acute leukemia. KMT2A-r AML cohort: ORR ~63%, CR/CRh ~23%; durable responses with bridge-to-alloHCT pathway. FDA accelerated approval Nov 2024 for KMT2A-r R/R acute leukemia (≥1 prior line). NPM1-mut cohort under priority review. Differentiation syndrome (~16%) is the signature AE — mandate corticosteroid hold + supportive care; rechallenge after resolution. QTc prolongation requires baseline + serial ECG with electrolyte correction. Ukraine: NOT registered, NOT reimbursed — major access barrier; international referral or EAP / compassionate-use only. Bibliographic record SRC-AUGMENT-101 is available; clinical claim linkage requires dual clinical sign-off.
Utilizado por
Esquema terapéutico
REG-REVUMENIB-AML- Revumenib en monoterapia para R/R KMT2A-reorganizado AML