Priority Review has been granted to Novartis’ New Drug Application (NDA) for capmatinib in the US.
Capmatinib (INC280) 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 by the FDA, it will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis.
Novartis was previously granted Breakthrough Therapy designation for capmatinib and, following the awarding of Priority Review, a decision is expected within six months.
There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC.
The NDA submission is supported by results from the GEOMETRY mono-1 Phase II study, which demonstrated an overall response rate of 67.9% and 40.6% among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1.
As part of the continued collaboration between Novartis and Foundation Medicine, companion diagnostics for capmatinib are in development for both tumour 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.
“Results of the GEOMETRY mono-1 trial clearly identify METex14 as an oncogenic driver and we are inspired to bring capmatinib, potentially the first METex14 targeted therapy, to patients and to reimagine medicine and outcomes for people with lung cancer,” said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.