Selpercatinib (1) – Retsevmo®
Non-small cell lung carcinoma (NSCLC), RET fusion+, after platinum-based chemotherapy and/or immunotherapy
Characteristics
| Start date | 15.03.2021 – Marketing authorisation: 11.02.2021 |
|---|---|
| Resolution | 02.09.2021 |
| INN | Selpercatinib |
| Brand name | Retsevmo® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-655 |
| 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 | Initial assessment |
| Regulatory status | Conditional Approval |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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Retsevmo as monotherapy is used to treat adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy after platinum-based chemotherapy and/or treatment with immunotherapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; after first-line therapy with a PD-1/PD-L1 antibody as monotherapy. | - 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 drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) cf. Annex VI to Section K of the Pharmaceutical Guideline or - Carboplatin in combination with nab-paclitaxel or - Monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment) |
| b) | Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; after first-line therapy with cytotoxic chemotherapy. | - Docetaxel (only for patients with PD-L1 negative tumours) or - Pemetrexed (only for patients with PD-L1 negative tumours and except in cases of predominantly squamous histology) or - nivolumab or - Pembrolizumab (only for patients with PD-L1 expressing tumours (TPS ≥ 1 %)) or - atezolizumab or - Docetaxel in combination with nintedanib (only for patients with PD-L1 negative tumours and adenocarcinoma histology). |
| c) | Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; after first-line therapy with a PD-1/PD-L1 antibody in combination with platinum-containing chemotherapy or after sequential therapy with a PD-1/PD-L1 antibody and platinum-containing chemotherapy. | Patient-specific therapy taking into account previous therapy and histology; choosing afatinib, pemetrexed, erlotinib, docetaxel, docetaxel in combination with ramucirumab, docetaxel in combination with nintedanib and vinorelbine. |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
- Clinical trials
- The LIBRETTO-001 basket trial is an uncontrolled clinical study with a prospective design that has been ongoing since May 2017.
- In the Phase 1 study, which has already been completed, the maximum tolerated dose was determined. In the ongoing Phase 2 study, the determined dose was administered.
a) Adults with RET-fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; following first-line treatment with a PD-1/PD-L1 antibody as monotherapy
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, the additional benefit of selpercatinib as monotherapy in adult patients with RET fusion-positive advanced NSCLC, in whom systemic therapy is indicated following first-line treatment with a PD-1/PD-L1 antibody, is not proven.
- Selpercatinib may represent a relevant treatment option in individual cases within this therapeutic indication.
b) Adults with RET-fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; following first-line treatment with cytotoxic chemotherapy
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, there is no evidence of additional benefit from selpercatinib as monotherapy in adult patients with RET fusion-positive advanced NSCLC, in whom systemic therapy is indicated following first-line treatment with cytotoxic chemotherapy, is not proven.
- Selpercatinib may represent a relevant treatment option in individual cases within the indicated therapeutic indication.
c) Adults with RET-fusion-positive advanced non-small cell lung cancer (NSCLC) for whom systemic therapy is indicated; following first-line treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy or following sequential treatment with a PD-1/PD-L1 antibody and platinum-based chemotherapy
- Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, there is no additional benefit of selpercatinib as monotherapy in adult patients with RET-fusion-positive advanced NSCLC, for whom systemic therapy is indicated following first-line treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy or following sequential therapy with a PD-1/PD-L1 antibody and platinum-based chemotherapy, is not proven.
- Selpercatinib may represent a relevant treatment option in individual cases within this therapeutic indication.
Courtesy translation only, please refer to the German original.
Associated procedures
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