Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

This is written in the approval document as:

TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Citation

EMD Serono, Inc. Tepmetko (tepotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214096s003lbl.pdf. Revised February 2023. Accessed October 30, 2024.

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Therapeutic response

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

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