Quizartinib
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| ID | DRUG-QUIZARTINIB |
|---|---|
| Tipo | Fármaco |
| Alegais | VanflytaКвізартиніб |
| Estado | reviewed 2026-04-25 | pending_clinical_signoff |
| Doenças | DIS-AML |
| Fontes | SRC-ELN-AML-2022 SRC-NCCN-AML-2025 |
Fatos sobre as drogas
| Classe | Inibidor seletivo da tirosina quinase FLT3-ITD do tipo II |
|---|---|
| Mecanismo | Type-II FLT3 inhibitor — binds the inactive (DFG-out) conformation of FLT3, highly selective for FLT3-ITD (limited activity vs FLT3-TKD/D835 mutations). Approved 2023 for newly-diagnosed FLT3-ITD+ AML in combination with intensive chemotherapy (induction + consolidation + maintenance) on the basis of QuANTUM-First trial. |
| Dose típica | Induction: 35.4 mg PO once daily on days 8-21 of induction cycle (with 7+3). Consolidation: 35.4-53 mg PO daily on days 6-19 of each consolidation. Maintenance (post-CR / post-HCT): 26.5-53 mg PO daily for up to 3 years. Dose-titration based on QTc; dose reduction with strong CYP3A4 inhibitors. |
| Ucrânia registada | Falso |
| NSZU reembolsado | Falso |
| Ucrânia verificada pela última vez | 2026-04-27 |
Avisos
- Prolongamento do QTc — torsadas de pontos, risco de morte súbita; monitorização ECG + gestão eletrólita obrigatória
Notas
Pivotal: QuANTUM-First (Erba et al., Lancet 2023) — quizartinib + intensive chemo + maintenance vs placebo+chemo in newly-dx FLT3-ITD+ AML; median OS 31.9 vs 15.1 mo (HR 0.78, p=0.032). Approved FDA July 2023. Type-II selectivity → does NOT cover FLT3-TKD/D835; for those use midostaurin (1L) or gilteritinib (R/R). Ukraine: NOT registered — access via named-patient import / EAP Daiichi Sankyo / cross-border. QTc monitoring + electrolyte correction mandatory throughout therapy.
Usado por
Esquema terapêutico
REG-QUIZARTINIB-7-3- 7+3 + indução de quizartinib + manutenção para FLT3-ITD+ AML 1L