Press release
Incyte Announces Acceptance and Priority Review of NDA for Capmatinib for Advanced Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) Priority Review for capmatinib is based on Phase 2 data in first-line and previously treated patients with MET
About this update from Incyte Corporation
[{"type":"text","content":"\n\nThe U.S. Food and Drug Administration (FDA) Priority Review for capmatinib is based on Phase 2 data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC)1\n\n\nNovartis has exclusive worldwide development and commercialization rights to capmatinib\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for capmatinib, an investigational, selective MET inhibitor, 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, a type of lung cancer with a particularly poor prognosis2,3.\n\n\nThere are currently no approved therapies that specifically target METex14 mutated advanced NSCLC. NSCLC accounts for approximately 85% of lung cancer diagnoses4. METex14 mutations occur in 3-4% of newly-diagnosed advanced NSCLC cases5 and is a recognized oncogenic driver6,7.\n\n\n“Patients with METex14 mutated advanced NSCLC, an aggressive form of the disease, often face a poor prognosis due to lack of available treatment options,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “We are pleased the FDA has accepted the NDA for capmatinib for Priority Review – a critical step toward providing the first METex14 mutation targeted therapy to this subset of lung cancer patients.”\n\n\nThe FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to 10 months for Standard Review. Capmatinib was previously granted Breakthrough Therapy designation by the FDA.\n\n\nThe NDA submission for capmatinib was supported by results from the Novartis-sponsored GEOMETRY mono-1 Phase 2 study, which demonstrated overall response rates of 67.9% (95% CI, 47.6 - 84.1)1 and 40.6% (95% CI, 28.9–53.1)1 among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The st...