# CD33 in acute myeloid leukaemia

1 EU-approved indication in acute myeloid leukaemia needs a CD33 result: gemtuzumab ozogamicin (1st line).

## 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) |

## 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)

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/cd33