# Acute myeloid leukaemia

The EU has approved 15 indications of 8 drugs in acute myeloid leukaemia. 13 of them need a biomarker result: FLT3 (7), PML::RARA (4), CD33 (1) and IDH1/2 (1).

## Approved indications

### CD33-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Gemtuzumab ozogamicin](https://oncolabels.com/drugs/gemtuzumab-ozogamicin) (Mylotarg) | CD33-positive | + daunorubicin and cytarabine | 1st line | Aged 15 years and above; de novo AML; except acute promyelocytic leukaemia (APL) |

### 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 |

### IDH1 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ivosidenib](https://oncolabels.com/drugs/ivosidenib) (Tibsovo) | IDH1 R132 | + azacitidine | 1st line | Not eligible to receive standard induction chemotherapy |

### PML::RARA fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Arsenic trioxide](https://oncolabels.com/drugs/arsenic-trioxide) (Trisenox) | PML::RARA fusion (defines the disease) | + all-trans-retinoic acid (ATRA) | Induction | Acute promyelocytic leukaemia only; Low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl |
| [Arsenic trioxide](https://oncolabels.com/drugs/arsenic-trioxide) (Trisenox) | t(15;17) translocation or PML/RAR-alpha gene | Monotherapy | Induction | Acute promyelocytic leukaemia only; After previous treatment should have included a retinoid and chemotherapy |
| [Arsenic trioxide](https://oncolabels.com/drugs/arsenic-trioxide) (Trisenox) | PML::RARA fusion (defines the disease) | + all-trans-retinoic acid (ATRA) | Consolidation | Acute promyelocytic leukaemia only; Newly diagnosed; low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl |
| [Arsenic trioxide](https://oncolabels.com/drugs/arsenic-trioxide) (Trisenox) | t(15;17) translocation and/or PML/RAR-alpha gene | Monotherapy | Consolidation | Acute promyelocytic leukaemia only; After previous treatment should have included a retinoid and chemotherapy; Relapsed/refractory |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Glasdegib](https://oncolabels.com/drugs/glasdegib) (Daurismo) | None | + low-dose cytarabine | 1st line | Not candidates for standard induction chemotherapy |
| [Venetoclax](https://oncolabels.com/drugs/venetoclax) (Venclyxto) | None | + a hypomethylating agent | 1st line | Ineligible for intensive chemotherapy |

## Label wording

- **Gemtuzumab ozogamicin** (Mylotarg), Acute myeloid leukaemia, 1st line: “MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mylotarg-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, induction: “Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (ATRA)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, induction: “Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, consolidation: “TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (ATRA)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, consolidation: “TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
• Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **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)
- **Venetoclax** (Venclyxto), Acute myeloid leukaemia, 1st line: “Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf)
- **Ivosidenib** (Tibsovo), Acute myeloid leukaemia, 1st line: “Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tibsovo-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)
- **Glasdegib** (Daurismo), Acute myeloid leukaemia, 1st line: “Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/daurismo-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