Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that MET Exon 14 (Deletion) 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.