Tepotinib
Active ingredient · 2 therapeutic classes
Sold as Tepmetko
- Drug class
- Cellular-Mesenchymal-Epithelial Transition Factor (C-Met) Kinase Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 3
Overview
Tepotinib is an active pharmaceutical ingredient in the Cellular-Mesenchymal-Epithelial Transition Factor (C-Met) Kinase Inhibitors group (L01EP). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 1 | May 1, 2026 |
| EU European Union | EMA | 1 | April 17, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
1 product
Uses
TEPMETKO is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
How to take
EUEuropean Union· EMA
1 product
Uses
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.
How to take
CACanada· Health Canada
1 product
Uses
TEPMETKO (tepotinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal- epithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations.
Documentation of MET tyrosine kinase receptor exon 14 (METex14) skipping alteration status based on a validated METex14 assay is required prior to treatment with TEPMETKO (see WARNINGS AND PRECAUTIONS). Efficacy in patients with NSCLC harbouring METex14 skipping alterations was based on objective response rate and duration of response in a single-arm study (see CLINICAL TRIALS).
1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): Of 313 patients with advanced NSCLC with METex14 skipping alterations in the VISION study who received 450 mg TEPMETKO once daily, 79% were 65 years or older, 41% were 75 years or older, and 8% were 85 years or older.
Sources & citations
- [1]MHRA (UK) · PLGB116480291 · revised May 1, 2026
- [2]European Medicines Agency · EMEA/H/C/005524 · revised April 17, 2026
- [3]Health Canada (DPD) · 02516322 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.