Regulatory approval

Published by the Health Canada.

Health Canada approved tepotinib for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymalepithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations.

This is written in the approval document as:

TEPMETKO (tepotinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymalepithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations.

Citation

EMD Serono, a Division of EMD Inc., Canada. Tepmetko (tepotinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00074821.PDF. Revised March 2024. Accessed June 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	MET Exon 14 (Splice Site)	Non-Small Cell Lung Cancer	Tepotinib
HC (1)	MET Exon 14 (Deletion)	Non-Small Cell Lung Cancer	Tepotinib