Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that MET Exon 14 (Deletion) status confers therapeutic sensitivity to Capmatinib in patients with Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration granted approval to capmatinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

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

TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

Citation

Novartis Pharmaceuticals Corporation. Tabrecta (capmatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213591s011lbl.pdf. Revised March 2024. Accessed October 30, 2024.