# Mogamulizumab

Mogamulizumab (Poteligeo, Kyowa Kirin Holdings B.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### T-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | Cutaneous T-cell lymphoma only; After at least one prior systemic therapy |

## Products

### Poteligeo

- Company: Kyowa Kirin Holdings B.V.
- Target: CCR4-directed monoclonal antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX09
- EU approval: 22 Nov 2018
- Label revised: 20 Oct 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/poteligeo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/poteligeo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo

Mechanism (SmPC section 5.1): Selectively binds to CCR4 on lymphocytes and T-cell malignancies, resulting in depletion of the target cells.

## Label wording

- **Mogamulizumab** (Poteligeo), T-cell lymphoma, 2nd line: “POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/poteligeo-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/mogamulizumab
