# Avelumab

Avelumab (Bavencio, Merck Europe B.V.) has 3 EU-approved indications in 3 tumour types.

## Approved indications

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + axitinib | 1st line, advanced | - |

### Urothelial carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Maintenance, advanced | Progression-free following platinum-based chemotherapy |

### Merkel cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Metastatic | - |

## Products

### Bavencio

- Company: Merck Europe B.V.
- Target: PD-L1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF04
- EU approval: 18 Sep 2017
- Label revised: 21 May 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/bavencio-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/bavencio-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/bavencio

Mechanism (SmPC section 5.1): A human IgG1 monoclonal antibody that binds PD-L1, blocking interaction with PD-1 and B7.1 to restore anti-tumour T-cell responses and induce tumour cell lysis via ADCC.

## Label wording

- **Avelumab** (Bavencio), Merkel cell carcinoma, metastatic: “Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/bavencio-epar-product-information_en.pdf)
- **Avelumab** (Bavencio), Urothelial carcinoma, maintenance, advanced: “Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/bavencio-epar-product-information_en.pdf)
- **Avelumab** (Bavencio), Renal cell carcinoma, 1st line, advanced: “Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/bavencio-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/avelumab