Selpercatinib (9) – Retsevmo®
Non-small cell lung cancer, RET-fusion+, first-line treatment
Characteristics
| Start date | 01.01.2026 – Marketing authorisation: 21.06.2022 |
|---|---|
| Resolution | 18.06.2026 |
| INN | Selpercatinib |
| Brand name | Retsevmo® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-1277 |
| ATC code | L01EX22 Other protein kinase inhibitors (L01EX) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Reassessment: G-BA limitation |
Studies and Results
- Clinical trials
- For the benefit assessment, the pharmaceutical manufacturer provided the results from the ongoing, open-label, randomised, controlled Phase IIILIBRETTO-431 trial, which is currently ongoing, to compare selpercatinib with a combination therapy consisting of cisplatin or carboplatin and pemetrexed, with or without pembrolizumab (hereinafter ‘platinum-based chemotherapy ± pembrolizumab’).
a) Adults with advanced RET-fusion-positive NSCLC with PD-L1 expression ≥ 50% of tumour cells; first-line treatment
- An additional benefit is not proven.
- Consequently, it is concluded that the data submitted are, on the whole, incomplete, which precludes a proper assessment.
b) Adults with advanced RET-fusion-positive NSCLC with PD-L1 expression < 50% of tumour cells; first-line treatment
- An additional benefit is not proven.
- It is therefore concluded that the data submitted are, on the whole, incomplete, which precludes a proper assessment.
Courtesy translation only, please refer to the German original.
Associated procedures
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