Tislelizumab (7) – Tevimbra®
Small cell lung cancer, first-line treatment, in combination with etoposide and platinum-based chemotherapy
Characteristics
| Start date | 01.10.2025 – Marketing authorisation: 02.05.2025 |
|---|---|
| Resolution | 19.03.2026 |
| INN | Tislelizumab |
| Brand name | Tevimbra® |
| Pharm. company | BeOne Medicines Germany GmbH |
| G-BA Procedure ID | D-1249 |
| ATC code | L01FF09 PD-1/PDL-1 inhibitors (L01FF) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
- Clinical trials
- In the dossier for the benefit assessment, the pharmaceutical manufacturer additionally submitted the results of the RATIONALE 312 registration trial on tislelizumab. This was a double-blind, randomised Phase III trial comparing tislelizumab with placebo, in each case in combination with etoposide and a platinum derivative (cisplatin or carboplatin).
Adults with advanced small-cell lung cancer (ES-SCLC); first-line treatment
- An additional benefit is not proven.
- The data from the RATIONALE 312 study are not suitable for assessing additional benefit. The control arm of the study consisted of the combination of etoposide and a platinum derivative (cisplatin or carboplatin). This does not correspond to the specified appropriate comparator therapy. Consequently, the appropriate comparator therapy has not been applied. Therefore, there are no suitable data available for assessing the additional benefit of tislelizumab in combination with etoposide and platinum-based chemotherapy.
- In conclusion, it is determined that an additional benefit is not proven for tislelizumab in combination with etoposide and platinum-based chemotherapy for the first-line treatment of advanced-stage small cell lung cancer (ES-SCLC).
Courtesy translation only, please refer to the German original.
Associated procedures
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