Novartis announced that capmatinib (INC280), a MET inhibitor, has been granted priority review statu

On February 11, 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) had accepted the New Drug Application (NDA) for the MET inhibitor capmatinib (INC280) and granted it priority review status. Capmatinib is being evaluated for the treatment of treatment-naive and previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations (METex14). If approved, capmatinib will become the first targeted therapy specifically indicated for advanced lung cancer with METex14 alterations, a disease associated with extremely poor prognosis² ³.

Priority review status is granted to therapies that the FDA deems to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. This designation shortens the FDA’s review period for an accepted NDA from the standard 10 months to 6 months. Prior to this, Novartis’ capmatinib had already been awarded breakthrough therapy designation.

Currently, there are no approved therapies specifically targeting advanced NSCLC with METex14 alterations. NSCLC accounts for approximately 85% of all lung cancer diagnoses⁴. METex14 alterations occur in 3%–4% of newly diagnosed patients with advanced NSCLC⁵ and are well-recognized oncogenic drivers⁶ ⁷. As part of the ongoing collaboration between Novartis and Foundation Medicine, Inc., a companion diagnostic for capmatinib is under development, covering both tumor tissue biopsy and liquid biopsy testing modalities. It is expected to be integrated into the FoundationOne®CDx * test panel and Foundation Medicine’s next-generation liquid biopsy platform, which is currently under FDA review. Foundation Medicine is a leading provider of comprehensive genomic profiling solutions for patients with advanced cancers, including NSCLC.

Capmatinib (INC280) is an investigational oral, potent and highly selective MET inhibitor. Novartis licensed the drug from Incyte Corporation in 2009. Under the terms of the licensing agreement, Incyte granted Novartis exclusive global rights to develop and commercialize capmatinib and certain backup compounds across all indications.