Capmatinib Granted FDA Breakthrough Therapy Designation for MET-Mutated Advanced NSCLC
Posted: Monday, September 16, 2019
On September 6, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to the MET inhibitor capmatinib as a first-line treatment for patients with metastatic MET exon14 skipping–mutated non–small cell lung cancer (NSCLC).
Research published in OncoTargets and Therapy and Journal of Clinical Oncology concluded that the cMET gene is an oncogenic driver. The MET mutation is seen in an estimated 3% to 4% of patients with NSCLC. These patients are generally older and often have a poor prognosis, which can limit treatment options.
This Breakthrough Therapy designation for capmatinib is based on efficacy data from the phase II GEOMETRY mono-1 study, which were presented at the 2019 American Society of Clinical Oncology Annual Meeting (Abstract 9004).