Lenvatinib (Kisplyx, 3) – Kisplyx®
Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab
Characteristics
| Start date | 15.12.2021 – Marketing authorisation: 26.11.2021 |
|---|---|
| Resolution | 07.07.2022 |
| INN | Lenvatinib |
| Brand name | Kisplyx® |
| Pharm. company | Eisai GmbH |
| G-BA Procedure ID | D-749 |
| ATC code | L01EX08 Other protein kinase inhibitors (L01EX) |
| DDD | 18 mg O |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
a) Adults with untreated, advanced renal cell carcinoma with a favourable risk profile (IMDC score 0)
- An additional benefit is not proven.
- A key prerequisite for an adjusted indirect comparison is the assumption of sufficient similarity between the studies. This includes the similarity of the patient population; however, this could not be adequately assessed in the present evaluation, as relevant data on the relevant patient populations from the CLEAR and KEYNOTE 426 studies are not available. Overall, based on the available data, it cannot be established with sufficient certainty that the patient populations are sufficiently similar for the indirect comparison.
b) Adults with untreated, advanced renal cell carcinoma with an intermediate (IMDC score 1–2) or unfavourable risk profile (IMDC score ≥ 3)
- An additional benefit is not proven.
- A key prerequisite for an adjusted indirect comparison is the assumption of sufficient similarity between the studies. This includes the similarity of the patient population; however, this could not be adequately assessed in the present evaluation, as relevant data on the relevant patient populations from the CLEAR and KEYNOTE 426 studies are not available. Overall, based on the available data, it cannot be established with sufficient certainty that the patient populations are sufficiently similar for the indirect comparison.
Courtesy translation only, please refer to the German original.
Associated procedures
| Lenvatinib (Kisplyx, 3) | Kisplyx® | Eisai GmbH | Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab | 2,790–4,180 | 100% additional benefit not proven | |
| Lenvatinib (Kisplyx, 2) | Kisplyx® | Eisai GmbH | Renal cell carcinoma (RCC) | 1,770–3,530 | 100% additional benefit not proven | |
| Lenvatinib (Kisplyx, 1) | Kisplyx® | Eisai GmbH | Renal cell carcinoma (RCC) |
0
1,200–3,300 |
100% Hint for minor additional benefit repealed |
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