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) |
| ICD-10 codes (AIS) | C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung |
| Alpha-ID codes (AIS) | I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Reassessment: G-BA limitation |
| Therapeutic indication of the resolution |
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Retsevmo is used as monotherapy for the treatment of adults with advanced RET-fusion-positive non-small cell lung cancer (NSCLC) who have not previously been treated with a RET inhibitor. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Erwachsene mit einem fortgeschrittenen RET-Fusions-positiven NSCLC mit einer PD-L1-Expression ≥ 50 % der Tumorzellen; Erstlinientherapie | |
| b) | Erwachsene mit einem fortgeschrittenen RET-Fusions-positiven NSCLC mit einer PD-L1-Expression < 50 % der Tumorzellen; Erstlinientherapie |
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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