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Novartis' New Drug Application for MET Inhibitor Capmatinib Accepted by FDA

NEW YORK – Novartis said Tuesday that the new drug application for its investigational MET inhibitor capmatinib (INC280) was accepted by the US Food and Drug Administration and granted priority review. Novartis expects the review to be completed within six months.

Capmatinib is currently being evaluated in untreated and previously treated patients with MET exon 14 skipping mutated advanced or metastatic non-small cell lung cancer. METex14 mutations tend to occur in 3 percent to 4 percent of newly diagnosed advanced NSCLC cases.

The NDA submission includes results from the Phase II GEOMETRY mono-1 study, which showed an overall response rate of 67.9 percent in previously untreated patients and 40.6 percent in previously treated patients. The median duration of response was 11.14 months in previously untreated patients and 9.72 months in previously treated patients. 

"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," Novartis' Chief Medical Officer John Tsai said in a statement.

Capmatinib was discovered by Incyte Corporation and licensed to Novartis in 2009. The agreement grants Novartis worldwide exclusive development and commercialization rights to capmatinib.

Novartis and Foundation Medicine are collaborating to develop a companion diagnostic for capmatinib that can assess both tumor tissue and liquid biopsies. The METex14 NSCLC indication for capmatinib will be included in FoundationOne CDx and a new version of Foundation Medicine's liquid biopsy platform, which is also under review with the FDA.

Pfizer, Merck KGaA, and AstraZeneca are also investigating MET inhibitors for METex14-mutated NSCLC.