Tislelizumab (3) – Tevimbra®
Non-small cell lung cancer, squamous cell, first-line, combination with carboplatin and either paclitaxel or nab-paclitaxel
Characteristics
| Start date | 01.01.2025 – Marketing authorisation: 08.07.2024 |
|---|---|
| Resolution | 18.06.2025 |
| INN | Tislelizumab |
| Brand name | Tevimbra® |
| Pharm. company | BeiGene Germany GmbH |
| G-BA Procedure ID | D-1127 |
| ATC code | L01FF09 PD-1/PDL-1 inhibitors (L01FF) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
Studies and Results
- Clinical trials
- In the dossier for the benefit assessment, the pharmaceutical manufacturer submitted the results of the RATIONALE 307 registration trial on tislelizumab. This was an open-label, randomised Phase III trial comparing tislelizumab in combination with carboplatin and either paclitaxel (arm A) or nab-paclitaxel (arm B) with carboplatin in combination with paclitaxel (arm C).
a) Adults with locally advanced squamous cell non-small cell lung cancer (NSCLC), NSCLC) who are not eligible for surgical resection or platinum-based chemoradiotherapy, or with metastatic squamous NSCLC, with PD-L1 expression ≥ 50%; first-line treatment
- The conclusion is that, for tislelizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced squamous cell NSCLC that is not eligible for surgical resection or platinum-based chemoradiotherapy, or for metastatic squamous NSCLC, an additional benefit is not proven.
b) Adults with locally advanced squamous cell non-small cell lung cancer (NSCLC, NSCLC) who are not eligible for surgical resection or platinum-based chemoradiotherapy, or with metastatic squamous NSCLC, with PD-L1 expression < 50%; first-line treatment
- In conclusion, it is established that for tislelizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced squamous cell NSCLC, which is not eligible for surgical resection or platinum-based chemoradiotherapy, or for metastatic squamous cell NSCLC, an additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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