Tepotinib

Tepotinib (Tepmetko, Merck Europe B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: MET (1).
Approved indications of Tepotinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
Leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping
Monotherapy
2L
advanced
After prior treatment with immunotherapy and/or platinum-based chemotherapy
Full text of section 4.1 (therapeutic indications)

TEPMETKO as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Label history

5 changes to the Tepmetko label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes