**Non-small cell lung cancer** Tevimbra is used to treat non-small cell lung cancer (NSCLC) that is advanced or has spread to other parts of the body (metastatic). Tevimbra is used together with chemotherapy as first-line treatment for patients whose cancer cannot be removed surgically (unresectable) or treated with a combination of chemotherapy and radiotherapy. These include patients whose cancers produce certain levels of a protein known as PD-L1. Tevimbra is also used on its own for patients with NSCLC who have already had chemotherapy. Gastric or gastroesophageal junction adenocarcinoma Tevimbra is used to treat adults with gastric or gastro-oesophageal junction adenocarcinoma (a type of cancer of the stomach or the transition between the stomach and oesophagus) that is locally advanced and unresectable or that is metastatic. It is used as first-line treatment together with chemotherapy containing platinum and fluoropyrimidine in patients whose cancer is HER2-negative (this means that the cancer does not have large quantities of a protein called HER2). In addition, Tevimbra should only be used when the cancer produces certain levels of PD‑L1, with a tumour area positivity (TAP) score of at least 5% (the TAP score is based on how much of the tumor is made up of PD-L1-positive tumor cells and immune cells). **Oesophageal cancer** Tevimbra is also used to treat squamous oesophageal cancer (cancer of the oesophagus, the passage from the mouth to the stomach) if the cancer is advanced, metastatic or unresectable. It is used after cancer treatment with platinum-based medicines has not worked well enough. It is used in combination with platinum-based medicines in patients whose tumours produce certain levels of PD-L1 with a TAP score of at least 5%. Oesophageal cancer is rare, and Tevimbra was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 13 November 2020. Further information on the orphan designation can be found on the EMA [website](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2357). Tevimbra contains the active substance tislelizumab.
Therapeutic Indication
### Therapeutic indication **Non-small cell lung cancer (NSCLC)** 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. **Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma** 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). **Oesophageal squamous cell carcinoma (OSCC)** 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). Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy.
Therapeutic Area (MeSH)
N/AATC Code
L01FF09
ATC Item
tislelizumab
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
N/AEMA Name
Tevimbra
Medicine Name
Tevimbra
Aliases
N/ANo risk management plan link.
