Tizveni
Withdrawn
This medicine's authorisation has been withdrawn
tislelizumab
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 5 July 2024, the European Commission withdrew the marketing authorisation for Tizveni (tislelizumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Beigene Ireland Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Tizveni was granted marketing authorisation in the EU on 19 April 2024 for the treatment of locally advanced or metastatic non-small cell lung cancer in adults. The marketing authorisation was initially valid for a 5-year period. Tizveni is an identical product to Tevimbra, which is authorised in the EU to treat locally advanced or metastatic non-small cell lung cancer and unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma in adults.
The European Public Assessment Report (EPAR) for Tizveni is updated to indicate that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Tizveni
- Active substance
- Tislelizumab
- International non-proprietary name (INN) or common name
- tislelizumab
- Therapeutic area (MeSH)
- Carcinoma, Non-Small-Cell Lung
- Anatomical therapeutic chemical (ATC) code
- L01FF09
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
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