Tepmetko

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tepotinib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 05/05/2022

Authorisation details

Product details
Name
Tepmetko
Agency product number
EMEA/H/C/005524
Active substance
Tepotinib hydrochloride monohydrate
International non-proprietary name (INN) or common name
tepotinib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01EX21
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
16/02/2022
Contact address

Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Product information

16/02/2022 Tepmetko - EMEA/H/C/005524 -

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

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.

Assessment history

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