Tepotinib (Tepmetko®) – Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients

Characteristics

Start date 01.03.2022
Resolution 01.09.2022
INN Tepotinib
Brand name Tepmetko®
Pharm. company Merck Europe B.V.
G-BA procedure ID 2022-03-01-D-781
Therapeutic area Oncological diseases
Reason for procedure Initial assessment

G-BA resolution "Anwendungsgebiet des Beschlusses" (German)

Tepmetko is used in adult patients with advanced non-small cell lung cancer (NSCLC) with alterations leading to METex14 skipping (exon14 skipping in the mesenchymal-epithelial transition factor gene) who require systemic therapy after platinum-based chemotherapy and/or treatment with immunotherapy.

Subpopulation Indication Comparator
a) Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14) skipping alterations after first-line therapy with a PD-1/PD-L1 antibody as monotherapy. Cisplatin in combination with a third-generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly plate epithelial histology)) or - carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for predominantly squamous histology). plate epithelial histology)) 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 advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14) skipping changes after first-line platinum-containing chemotherapy. Docetaxel (only for patients with PD-L1 negative tumours) or - Pemetrexed (only for patients with PD-L1 negative tumours and except in the case of predominantly squamous histology) or - Nivolumab or - Pembrolizumab (only for patients with PD-L1 expressing tumours, tumour proportion tumours, tumour proportion score (TPS) ≥ 1 %) or - atezolizumab or - docetaxel in combination with nintedanib (only for patients with PDL1 negative tumours and adenocarcinoma histology)
c) Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14) skipping changes 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/PDL1 antibody and platinum-containing chemotherapy. Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14) skipping changes 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/PDL1 antibody and platinum-containing chemotherapy.

9. Associated procedures



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