publication date: Feb. 21, 2020

Drugs & Targets

FDA grants capmatinib priority review in NSCLC indication

FDA has granted Priority Review to capmatinib’s (INC280) New Drug Application.

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. 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 prognosis.

FDA previously granted Novartis Breakthrough Therapy designation for capmatinib.

There are no approved therapies that specifically target METex14 mutated advanced NSCLC. METex14 mutations occur in 3 to 4% of newly diagnosed advanced NSCLC cases and is a recognized oncogenic driver.

As part of the continued collaboration between Novartis and Foundation Medicine Inc., companion diagnostics for capmatinib are in development for both tumor tissue and liquid biopsies to be included on FoundationOneCDx and the forthcoming version of Foundation Medicine’s liquid biopsy platform, which is under FDA review.

“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,” John Tsai, CEO and head of global drug development at Novartis, said in a statement.

Results from the GEOMETRY mono-1 phase II study support the NDA. The study demonstrated an overall response rate of 67.9% (95% CI, 47.6 – 84.1)  and 40.6% (95% CI, 28.9 – 53.1) among treatment-naïve and previously treated patients, based on the Blinded Independent Review Committee assessment per RECIST v1.1.

The study … Continue reading FDA grants capmatinib priority review in NSCLC indication

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