# Tebentafusp

Tebentafusp (Kimmtrak, Immunocore Ireland Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: HLA-A*02:01 (1).

## Approved indications

### Uveal melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HLA-A*02:01-positive | Monotherapy | Advanced | - |

## Products

### Kimmtrak

- Company: Immunocore Ireland Limited
- Target: gp100/HLA-A*02:01 × CD3 bispecific fusion protein
- Class: Other antineoplastic agents
- ATC: L01XX75
- EU approval: 1 Apr 2022
- Label revised: 9 Dec 2025
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/kimmtrak-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/kimmtrak-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/kimmtrak

Mechanism (SmPC section 5.1): Its TCR arm binds gp100 peptide presented by HLA-A*02:01 on uveal melanoma cells and its anti-CD3 arm binds T cells, redirecting and activating polyclonal T cells to lyse tumour cells.

## Label wording

- **Tebentafusp** (Kimmtrak), Uveal melanoma, advanced: “KIMMTRAK is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kimmtrak-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/tebentafusp