Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that MET Exon 14 (Splice Site) 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. Novartis Pharmaceuticals Corporation. Tabrecta (capmatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s004lbl.pdf. Revised August 2022. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2022-08-10	Food and Drug Administration	Indication received traditional approval.