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) |
| ICD-10 codes (AIS) | C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung |
| Alpha-ID codes (AIS) | I111155Carcinoma of the upper lobe bronchus, I116692Small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Tevimbra, in combination with etoposide and platinum-based chemotherapy, is used for the first-line treatment of advanced small cell lung cancer (extensive-stage small cell lung cancer, ES-SCLC) in adult patients. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Erwachsene mit kleinzelligem Lungenkarzinom im fortgeschrittenen Stadium (ES-SCLC); Erstlinie |
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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