Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that MET Exon 14 (Splice Site) status confers therapeutic sensitivity to Tepotinib in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. EMD Serono, Inc. Tepmetko (tepotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214096s000lbl.pdf. Revised February 2021. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-02-15	Food and Drug Administration	Indication received traditional approval.
2021-02-03	Food and Drug Administration	Indication received accelerated approval.