# Gemtuzumab ozogamicin

Gemtuzumab ozogamicin (Mylotarg, Pfizer Europe MA EEIG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: CD33 (1).

## Approved indications

### Acute myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| CD33-positive | + daunorubicin and cytarabine | 1st line | Aged 15 years and above; de novo AML; except acute promyelocytic leukaemia (APL) |

## Products

### Mylotarg

- Company: Pfizer Europe MA EEIG
- Target: CD33-directed antibody-drug conjugate
- EU approval: 19 Apr 2018
- Label revised: 17 Sep 2025
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/mylotarg-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/mylotarg-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/mylotarg

Mechanism (SmPC section 5.1): It binds CD33-expressing cells, internalises, and releases calicheamicin to induce double-stranded DNA breaks and apoptotic cell death.

## 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/drugs/gemtuzumab-ozogamicin