Tislelizumab (2) – Tevimbra®
Non-small cell lung cancer, non-squamous, PD-L1 expression ≥ 50%, first-line, combination with pemetrexed and platinum-containing chemotherapy
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-1126 |
| ATC code | L01FF09 PD-1/PDL-1 inhibitors (L01FF) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling ACT change |
Studies and Results
- Clinical trials
- In the dossier for the benefit assessment, the pharmaceutical manufacturer submitted the results of the RATIONALE 304 registration trial on tislelizumab. This was an open-label, randomised Phase IIIstudy comparing tislelizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) against pemetrexed in combination with platinum-based chemotherapy (cisplatin or carboplatin).
Adults with locally advanced non-squamous non-small cell lung cancer (NSCLC), NSCLC) who are not eligible for surgical resection or platinum-based chemoradiotherapy, or with metastatic non-squamous NSCLC, with PD-L1 expression ≥ 50 %, and without EGFR or ALK aberrations; First-line treatment
- An additional benefit is not proven.
- Consequently, there are no suitable data available to assess the additional benefit of tislelizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin).
- Consequently, it is concluded that for tislelizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the first-line treatment of locally advanced non--squamous cell NSCLC that is not eligible for surgical resection or platinum-based chemoradiotherapy, or for metastatic non-squamous cell NSCLC with PD-L1 expression ≥ 50 %, without EGFR or ALK aberrations. The additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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