# Quizartinib

Source: https://onco.cc/drugs/quizartinib/  
OnCo record `quizartinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Quizartinib is a more selective FLT3 blocker that, added to chemotherapy, roughly doubled median survival in the highest-risk FLT3 subtype.

## Summary

QuANTUM-First (n=539, FLT3-ITD, age 18-75): median OS 31.9 vs 15.1 months (HR 0.776), including patients not transplanted; benefit sustained in the maintenance phase analysis. Approved July 2023 with a boxed warning for QT prolongation and a REMS. Earlier rejected (2019) in the relapsed setting after QuANTUM-R despite a positive OS result. Approved in Japan 2019.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Vanflyta
- Modality: Small-molecule kinase inhibitor (FLT3-ITD, type II)
- Mechanism: Type II FLT3 inhibitor binding the inactive DFG-out conformation; potent against ITD, inactive against TKD resistance mutations (D835).
- Approvals: US 2023: Newly diagnosed FLT3-ITD AML with 7+3, consolidation, and maintenance; Japan 2019: Relapsed/refractory FLT3-ITD AML
- Dosing: Oral; 35.4 mg once daily on days 8-21 of induction and consolidation; 26.5 mg daily for 2 weeks then 53 mg daily as maintenance for up to 36 cycles
- Toxicity (grade 3+): Febrile neutropenia 43%; Neutropenia 20%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Quizartinib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Quizartinib

## Connected records

- biomarkers: [FLT3-ITD (internal tandem duplication)](https://onco.cc/biomarkers/flt3-itd/), [FLT3-TKD (D835 and I836 tyrosine kinase domain mutations)](https://onco.cc/biomarkers/flt3-tkd/)
- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Acute myeloid leukaemia in older or unfit patients](https://onco.cc/cancers/aml-older-unfit/), [FLT3-mutated acute myeloid leukaemia](https://onco.cc/cancers/aml-flt3/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FLT3](https://onco.cc/targets/flt3/), [STAT5 (STAT5A, STAT5B)](https://onco.cc/targets/stat5/)
- companies: [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- trials: [Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission](https://onco.cc/trials/nct06824168/), [QuANTUM-First](https://onco.cc/trials/quantum-first/), [Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood](https://onco.cc/trials/nct03793478/)
- pairings: [FLT3 inhibitor + intensive chemotherapy](https://onco.cc/pairings/flt3i-plus-7-3/)
- key papers: [ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia](https://onco.cc/key-papers/paper-admiral-gilteritinib-flt3-nejm-2019/), [QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML](https://onco.cc/key-papers/paper-quantum-first-quizartinib-lancet-2023/)
- pathways: [Acute myeloid leukaemia (KEGG map)](https://onco.cc/pathways/aml-signalling/)

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