Revumenib
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| ID | DRUG-REVUMENIB |
|---|---|
| Tipo | Fármaco |
| Alegais | RevuforjРевуменіб |
| Estado | reviewed 2026-04-30 | pending_clinical_signoff |
| Doenças | DIS-AML |
| Fontes | SRC-NCCN-AML-2025 |
Fatos sobre as drogas
| Classe | Inibidor da interação seletiva da 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. |
| Dose 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. |
| Ucrânia registada | Falso |
| NSZU reembolsado | Falso |
| Ucrânia verificada pela última vez | 2026-04-30 |
Avisos
- Síndrome de diferenciação — fatal se não reconhecido; corticosteróides + interrupção da dose obrigatório (~16% no AUGMENTO-101)
- QTc prolongation — baseline + serial ECG; correct K+ ≥4.0 mEq/L and 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.
Usado por
Esquema terapêutico
REG-REVUMENIB-AML- Revumenib em monoterapia para R/R KMT2A-rearranjado AML