The U.S. Food and Drug Administration have accepted and granted priority review to Novartis's capmatinib's (INC280). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC). If approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, an aggressive type of lung cancer. Novartis was previously granted breakthrough therapy designation for capmatinib.
There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC. NSCLC accounts for approximately 85% of lung cancer diagnoses. As part a collaboration between Novartis and Foundation Medicine, companion diagnostics for capmatinib are in development for both tumor tissue and liquid biopsies to be included on FoundationOne CDx and the forthcoming version of Foundation Medicine's liquid biopsy platform, which is currently under review with the FDA.
The new drug application submission for capmatinib is supported by results from the a Phase II study, which demonstrated an overall response rate of 67.9% and 40.6% among treatment-naïve and previously treated patients, respectively. The study also demonstrated that capmatinib provided durable responses among all patients.
All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response.
Read the full Novartis release