# FLT3 in acute myeloid leukaemia

7 EU-approved indications in acute myeloid leukaemia need a FLT3 result: quizartinib (induction), quizartinib (consolidation), quizartinib (maintenance), gilteritinib (2nd line), midostaurin (induction), midostaurin (consolidation) and midostaurin (maintenance).

## Approved indications

### FLT3 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Midostaurin](https://oncolabels.com/drugs/midostaurin) (Rydapt) | FLT3 mutation | + standard daunorubicin and cytarabine | Induction | Then maintenance monotherapy |
| [Quizartinib](https://oncolabels.com/drugs/quizartinib) (Vanflyta) | FLT3-ITD | + standard cytarabine and anthracycline induction chemotherapy | Induction | Then maintenance monotherapy |
| [Midostaurin](https://oncolabels.com/drugs/midostaurin) (Rydapt) | FLT3 mutation | Monotherapy | Maintenance | After standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy; Complete response |
| [Quizartinib](https://oncolabels.com/drugs/quizartinib) (Vanflyta) | FLT3-ITD | Monotherapy | Maintenance | After quizartinib + standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy without progression |
| [Midostaurin](https://oncolabels.com/drugs/midostaurin) (Rydapt) | FLT3 mutation | + high-dose cytarabine | Consolidation | After standard daunorubicin and cytarabine induction chemotherapy |
| [Quizartinib](https://oncolabels.com/drugs/quizartinib) (Vanflyta) | FLT3-ITD | + standard cytarabine consolidation chemotherapy | Consolidation | After quizartinib + standard cytarabine and anthracycline induction chemotherapy |
| [Gilteritinib](https://oncolabels.com/drugs/gilteritinib) (Xospata) | FLT3 mutation | Monotherapy | 2nd line | Relapsed or refractory |

## 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)
- **Gilteritinib** (Xospata), Acute myeloid leukaemia, 2nd line: “Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xospata-epar-product-information_en.pdf)
- **Midostaurin** (Rydapt), Acute myeloid leukaemia, induction: “in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rydapt-epar-product-information_en.pdf)
- **Midostaurin** (Rydapt), Acute myeloid leukaemia, consolidation: “in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rydapt-epar-product-information_en.pdf)
- **Midostaurin** (Rydapt), Acute myeloid leukaemia, maintenance: “in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rydapt-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/tumours/acute-myeloid-leukaemia/flt3