# Toripalimab

Toripalimab (Loqtorzi, Topalliance Biosciences Europe Limited) has 2 EU-approved indications in 2 tumour types.

## Approved indications

### Oesophageal cancer

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

### Nasopharyngeal carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + cisplatin and gemcitabine | 1st line, advanced | Recurrent disease not amenable to surgery or radiotherapy |

## Products

### Loqtorzi

- Company: Topalliance Biosciences Europe Limited
- Target: PD-1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF13
- EU approval: 19 Sep 2024
- Label revised: 4 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/loqtorzi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/loqtorzi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/loqtorzi

Mechanism (SmPC section 5.1): Toripalimab binds to the PD-1 receptor, blocking interaction with PD-L1 and PD-L2 to release PD-1 pathway-mediated inhibition of the anti-tumour immune response.

## Label wording

- **Toripalimab** (Loqtorzi), Nasopharyngeal carcinoma, 1st line, advanced: “LOQTORZI, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/loqtorzi-epar-product-information_en.pdf)
- **Toripalimab** (Loqtorzi), Oesophageal cancer, 1st line, advanced: “LOQTORZI, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/loqtorzi-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/toripalimab
