Basic Information
Tepmetko
Regulatory Information
EMEA/H/C/005524
February 16, 2022
December 16, 2021
3
May 21, 2024
Company Information
the netherlands
Gustav Mahlerplein 102 1082 MA Amsterdam
Merck Europe BV
Drug Classification
Active Substances Detail
Tepotinib hydrochloride monohydrate
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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.
Overview Summary
Tepmetko is a cancer medicine that is used to treat adults with non-small cell lung cancer (NSCLC) when the cancer is advanced and its cells have particular genetic mutations (changes) leading to ‘mesenchymal-epithelial transition factor gene exon 14’ (METex14) skipping. This means that the cancer cells make an abnormal form of a protein called MET because a part of the MET gene known as exon 14 is not used. Tepmetko is used when the patient needs further treatment after receiving immunotherapy or platinum-based chemotherapy, or both. Tepmetko contains the active substance tepotinib.