# Quizartinib

Quizartinib (Vanflyta, Daiichi Sankyo Europe GmbH) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: FLT3 (3).

## Approved indications

### Acute myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| FLT3-ITD | + standard cytarabine and anthracycline induction chemotherapy | Induction | Then maintenance monotherapy |
| FLT3-ITD | Monotherapy | Maintenance | After quizartinib + standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy without progression |
| FLT3-ITD | + standard cytarabine consolidation chemotherapy | Consolidation | After quizartinib + standard cytarabine and anthracycline induction chemotherapy |

## Products

### Vanflyta

- Company: Daiichi Sankyo Europe GmbH
- Target: FLT3 inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX11
- EU approval: 6 Nov 2023
- Label revised: 19 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/vanflyta-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/vanflyta-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta

Mechanism (SmPC section 5.1): Quizartinib competitively binds the ATP-binding pocket of FLT3 to inhibit kinase activity, preventing autophosphorylation, downstream receptor signalling, and FLT3-ITD-dependent proliferation.

## Label wording

- **Quizartinib** (Vanflyta), Acute myeloid leukaemia, induction: “VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vanflyta-epar-product-information_en.pdf)
- **Quizartinib** (Vanflyta), Acute myeloid leukaemia, consolidation: “VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vanflyta-epar-product-information_en.pdf)
- **Quizartinib** (Vanflyta), Acute myeloid leukaemia, maintenance: “VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vanflyta-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/quizartinib