Tevimbra is a cancer medicine used to treat the following: * Non\-small cell lung cancer (NSCLC), a type of lung cancer * Small cell lung cancer (SCLC), a type of lung cancer * Gastric or gastroesophageal junction adenocarcinoma, a type of stomach cancer * Oesophageal squamous cell carcinoma (OSCC), a type of oesophageal (gullet) cancer * Nasopharyngeal carcinoma (NPC), a type of head and neck cancer. The medicine is used in adults. Tevimbra is mainly used when the cancer is advanced, unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body), or when other treatments do not work. For some cancers, Tevimbra is only given to patients whose tumours produce certain levels of a protein known as PD\-L1\. In some patients with NSCLC, Tevimbra can be given before (neoadjuvant treatment) and after (adjuvant treatment) surgery. Depending on the cancer being treated, Tevimbra can be used on its own or in combination with other cancer medicines. Tevimbra contains the active substance tislelizumab.
Therapeutic Indication
**Non\-small cell lung cancer (NSCLC)** 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\). 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. **Small Cell Lung Cancer (SCLC)** Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first\-line treatment of adult patients with extensive\-stage SCLC. **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. **Nasopharyngeal carcinoma (NPC)** 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.
Therapeutic Area (MeSH)
ATC Code
L01FF09
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Tevimbra
Medicine Name
Tevimbra
Aliases
N/ANo risk management plan link.
