Tislelizumab
Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors
Sold as Tizveni · Tevimbra
- Drug class
- Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 3
Overview
Tislelizumab is an active pharmaceutical ingredient in the Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors group (L01FF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| EU European Union | EMA | 1 | May 27, 2026 |
| GB United Kingdom | MHRA | 1 | May 1, 2026 |
| CA Canada | Health Canada | 1 | May 19, 2026 |
EUEuropean Union· EMA
1 product
Uses
1). 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.
3 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.
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.
GBUnited Kingdom· MHRA
1 product
Uses
1). 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.
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.
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.
CACanada· Health Canada
1 product
1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (1)
Sources & citations
- [1]European Medicines Agency · EMEA/H/C/005919 · revised May 27, 2026
- [2]MHRA (UK) · PLGB537890003 · revised May 1, 2026
- [3]Health Canada (DPD) · 02564009 · revised May 19, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.