Tepmetko (tepotinib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tepotinib
- Company
- Merck Europe B.V.
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Wed 16 Feb 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005524
- ATC
- L01EX21
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.