Selpercatinib (4) – Retsevmo®
Non-small cell lung cancer (NSCLC), RET fusion+, first-line
Characteristics
| Start date | 01.07.2022 – Marketing authorisation: 21.06.2022 |
|---|---|
| Resolution | 15.12.2022 repealed |
| Limitation date | 31.12.2025 |
| INN | Selpercatinib |
| Brand name | Retsevmo® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-832 |
| 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 |
| DDD | 0.32 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | New therapeutic indication |
| Regulatory status | Conditional Approval |
| Therapeutic indication of the resolution |
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This is an indication extension for selpercatinib as monotherapy for the treatment of advanced RET fusion-positive non-small cell lung cancer (NSCLC) in first-line adults who have not previously been treated with a RET inhibitor. The indication for treatment of adults with advanced RET-fusion-positive non-small cell lung cancer (NSCLC) who have received systemic therapy after platinum-chemotherapy and/or treatment with immunotherapy, is the subject of the benefit assessment decision of selpercatinib dated 02 September 2021. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% of tumour cells; first-line treatment. | Pembrolizumab as monotherapy |
| b) | Adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% of tumour cells; first-line treatment. | - cisplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or - docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)), or - carboplatin in combination with nab-paclitaxel or - Pembrolizumab in combination with pemetrexed and platinum-containing chemotherapy (only for patients without EGFR- or ALK-positive tumour mutations and with non-squamous histology) or - Pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel (only with squamous histology) or - monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + historical comparison) |
| Reason for dividing into subpopulations (G-BA) | Disease stage |
- Clinical trials
- The LIBRETTO-001 basket trial is an uncontrolled clinical study with a prospective design that has been ongoing since May 2017.
- Cohort 2, which is relevant to the present therapeutic indication, included patients with advanced or metastatic solid tumours with RET fusion who had not previously received standard therapy.
a) Adults with advanced RET-fusion-positive non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% of tumour cells; first-line treatment
- Pembrolizumab was identified as the appropriate comparator therapy.
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adults with RET-fusion-positive advanced NSCLC with PD-L1 expression ≥ 50% of tumour cells in first-line treatment is not proven.
- Overall assessment
- The results of the single-arm LIBRETTO-001 study alone are not suitable for assessing the additional benefit of selpercatinib, as they do not allow for a comparison with the appropriate comparator therapy.
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adult patients with RET fusion-positive advanced NSCLC in the first-line setting is not proven.
b) Adults with advanced RET-fusion-positive non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% of tumour cells; first-line treatment
- The appropriate comparator therapy comprises platinum-based (cisplatin/carboplatin) chemotherapy, which may also be combined with an immune checkpoint inhibitor (pembrolizumab), with or without pemetrexed, paclitaxel or nab-paclitaxel.
- For adults with an ECOG performance status of 2, monochemotherapy may also be considered as an alternative.
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adults with RET-fusion-positive advanced NSCLC with PD-L1 expression in < 50% of tumour cells in first-line treatment is not proven.
- Overall assessment
- The results of the single-arm LIBRETTO-001 study presented here are not, on their own, suitable for assessing the additional benefit of selpercatinib, as they do not allow for a comparison with the appropriate comparator therapy.
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adult patients with RET fusion-positive advanced NSCLC in the first-line setting is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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