Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

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	Capmatinib
FDA (1)	MET Exon 14 (Deletion)	Non-Small Cell Lung Cancer	Capmatinib