What is the role of combined capmatinib (Tabrecta) in the treatment of non–small cell lung cancer (NSCLC)?

Updated: Jun 05, 2020
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Answer

Resistance to EGFR TKI therapy can result from mesenchymal-epithelial transition (MET) exon 14 skipping. In May 2020, the FDA approved capmatinib (Tabrecta) for treatment of adults with metastatic NSCLC with exon 14 skipping. Approval was based on a study in which the ORR in treatment-naïve patients (n=28) was 68% (complete response in 4%, partial response in 64%) and the ORR in previously treated patients (n=69) was 41%, with all having a partial response. Median duration of response was 12.6 months in treatment-naïve patients and 9.7 months in previously treated patients. [169]

The FDA also approved a companion diagnostic for capmatinib, the FoundationOne CDx assay (F1CDx). F1CDx is a next-generation sequencing–based, in vitro diagnostic device that detects MET exon 14 skipping mutations, as well as other mutations. [169]


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