Tizveni (tislelizumab)
- Region
- 🇪🇺 EU
- Active substance
- tislelizumab
- Company
- BeiGene Ireland Ltd
- Status
- Withdrawn
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 22 Feb 2024
- EU approval
- Fri 19 Apr 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005542
- ATC
- L01FF09
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tevimbra Authorised · Beone Medicines Ireland Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.