Cemiplimab (2) – Libtayo®
Non-small cell lung carcinoma (NSCLC), first-line
Characteristics
| Start date | 01.08.2021 – Marketing authorisation: 21.06.2021 |
|---|---|
| Resolution | 20.01.2022 |
| INN | Cemiplimab |
| Brand name | Libtayo® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-705 |
| ATC code | L01FF06 PD-1/PDL-1 inhibitors (L01FF) |
| DDD | 17 mg P |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Regulatory status | Conditional Approval |
| Specialty | Bundling |
Studies and Results
- Clinical trials
- The R2810-ONC-1624 trial is an ongoing, open-label RCT comparing cemiplimab with platinum-based combination chemotherapy.
Adults with locally advanced NSCLC who are not candidates for definitive chemoradiotherapy, or with metastatic NSCLC that expresses PD-L1 in ≥ 50% of tumour cells and without EGFR, ALK or ROS1 aberrations; first-line treatment
- An additional benefit is not proven.
- Overall, there are therefore no suitable data available to assess the additional benefit of cemiplimab compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Cemiplimab (6) | Libtayo® | Regeneron GmbH | Cutaneous squamous cell carcinoma, following resection and radiotherapy, adjuvant therapy | 690–1,420 | 100% Indication of non-quantifiable additional benefit | |
| Cemiplimab (5) | Libtayo® | Sanofi-Aventis Deutschland GmbH | Non-small cell lung cancer, first-line, PD-L1 expression ≥ 1 %, combination with platinum-based chemotherapy | 9,540–12,900 | 100% additional benefit not proven | |
| Cemiplimab (4) | Libtayo® | Sanofi-Aventis Deutschland GmbH | Cervix carcinoma, pretreated | 380–1,450 | 50% Indication of considerable additional benefit | |
| Cemiplimab (3) | Libtayo® | Sanofi-Aventis Deutschland GmbH | Basal cell carcinoma (BCC), locally advanced or metastasised | 83–155 | 97% Hint for minor additional benefit | |
| Cemiplimab (2) | Libtayo® | Sanofi-Aventis Deutschland GmbH | Non-small cell lung carcinoma (NSCLC), first-line | 4,130–5,110 | 100% additional benefit not proven | |
| Cemiplimab (1) | Libtayo® | Sanofi-Aventis Deutschland GmbH | Squamous cell carcinoma (SCC) | 450–1,400 | 100% additional benefit not proven |
<< List of all resolutions