# Retifanlimab

Retifanlimab (Zynyz, Incyte Biosciences Distribution B.V.) has 2 EU-approved indications in 2 tumour types.

## Approved indications

### Anal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + carboplatin and paclitaxel | 1st line, advanced | Squamous cell carcinoma only |

### Merkel cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 1st line, advanced | Not amenable to curative surgery or radiation therapy |

## Products

### Zynyz

- Company: Incyte Biosciences Distribution B.V.
- Target: PD-1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF10
- EU approval: 19 Apr 2024
- Label revised: 18 Mar 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/zynyz-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/zynyz-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zynyz

Mechanism (SmPC section 5.1): Retifanlimab is a monoclonal antibody that binds the PD-1 receptor and blocks interaction with PD-L1 and PD-L2, potentiating T-cell anti-tumour activity.

## Label wording

- **Retifanlimab** (Zynyz), Anal cancer, 1st line, advanced: “ZYNYZ is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zynyz-epar-product-information_en.pdf)
- **Retifanlimab** (Zynyz), Merkel cell carcinoma, 1st line, advanced: “ZYNYZ is indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zynyz-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/retifanlimab