Tevimbra (tislelizumab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

BeiGene Ireland Ltd. Tevimbra (tislelizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf. Revised July 2024. Accessed August 22, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

Tevimbra in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on >= 50% of tumor cells with no EGFR or ALK positive mutations and who have (i) locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or (ii) metastatic NSCLC.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Pemetrexed, Tislelizumab
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Pemetrexed, Tislelizumab