Basic Information
Tizveni
Regulatory Information
EMEA/H/C/005542
April 19, 2024
February 22, 2024
May 23, 2024
Company Information
Ireland
10 Earlsfort Terrace Dublin D02 T380
BeiGene Ireland Ltd.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Non-small cell lung cancer (NSCLC) Tizveni in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer 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. Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC. Tizveni as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
Overview Summary
Tizveni is a cancer medicine for non-small cell lung cancer (NSCLC). It is used in adults to treat: - non-squamous NSCLC, in combination with pemetrexed (a chemotherapy medicine that kills cells that are dividing, such as cancer cells) and cisplatin or carboplatin (other chemotherapy medicines), when the disease is metastatic (meaning it has spread to other parts of the body) or when the tumour is locally advanced (meaning it has spread into tissues around the lungs but not to other parts of the body) and cannot be treated with surgery or platinum-based medicines. It is used when at least 50% of the tumour cells have the protein PD-L1 on their surface and the cancer has no mutations (changes) in the EGFR and ALK genes; - squamous NSCLC, in combination with carboplatin and paclitaxel or nab-paclitaxel (other cancer medicines), when the disease is metastatic or when the tumour is locally advanced and cannot be treated with surgery or platinum-based medicines; - NSCLC that is locally advanced or metastatic, when cancer treatment with platinum-based medicines has not worked well enough. In these patients, Tizveni is used on its own. Patients whose cancer has an EGFR or ALK mutation should also have received medicines that target these mutations before starting Tizveni. Tizveni contains the active substance tislelizumab.