# Tislelizumab

Tislelizumab (Tevimbra, Beone Medicines Ireland Limited) has 10 EU-approved indications in 5 tumour types. 3 need a biomarker result: PD-L1 (3).

## Approved indications

### Small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + etoposide and platinum chemotherapy | 1st line, advanced | - |

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + platinum-containing chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| None | Monotherapy | Adjuvant, early | After neoadjuvant tislelizumab + platinum-containing chemotherapy and surgical resection; High risk of recurrence |
| None | + carboplatin and paclitaxel or nab-paclitaxel | 1st line, advanced | Squamous only; For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation |
| PD-L1 expression on ≥ 50% of tumour cells, EGFR/ALK-negative | + pemetrexed and platinum-containing chemotherapy | 1st line, advanced | Non-squamous only; For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation |
| None | Monotherapy | 2nd line, advanced | After prior platinum-based therapy; patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies |

### Gastric and GEJ adenocarcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 TAP score ≥ 5%, HER2-negative | + platinum and fluoropyrimidine-based chemotherapy | 1st line, advanced | - |

### Oesophageal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 TAP score ≥ 5% | + platinum-based chemotherapy | 1st line, advanced | Squamous cell carcinoma only |
| None | Monotherapy | 2nd line, advanced | Squamous cell carcinoma only; After prior platinum-based chemotherapy |

### Nasopharyngeal carcinoma

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

## Products

### Tevimbra

- Company: Beone Medicines Ireland Limited
- Target: PD-1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF09
- EU approval: 15 Sep 2023
- Label revised: 24 Sep 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tevimbra-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tevimbra

Mechanism (SmPC section 5.1): Tislelizumab binds PD-1 and blocks PD-L1 and PD-L2 binding, inhibiting negative signaling and enhancing T-cell functional activity.

## Label wording

- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, neoadjuvant, early: “Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, adjuvant, early: “Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, 1st line, advanced: “Tevimbra, in combination with pemetrexed and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, 1st line, advanced: “Tevimbra, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of adult patients with squamous NSCLC who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, 2nd line, advanced: “Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Small cell lung cancer, 1st line, advanced: “Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Gastric and GEJ adenocarcinoma, 1st line, advanced: “Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Oesophageal cancer, 1st line, advanced: “Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score ≥ 5% (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Oesophageal cancer, 2nd line, advanced: “Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Nasopharyngeal carcinoma, 1st line, advanced: “Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-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/tislelizumab