Research & Development
Incyte receives FDA priority review for Capmatinib NDA to treat advanced non-small cell lung cancer
11 February 2020 -

Biopharmaceutical company Incyte (Nasdaq:INCY) said on Tuesday that the US Food and Drug Administration (FDA) has awarded its Priority Review to the New Drug Application (NDA) for capmatinib as the 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).

Upon US FDA approval, the company's capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis.

There are no approved therapies that target METex14 mutated advanced NSCLC, which accounts for 85% of lung cancer diagnoses.

Capmatinib (INC280) is reportedly an investigational, oral and selective MET inhibitor discovered by Incyte and licensed to Novartis. METex14 mutations occur in 3-4% of newly-diagnosed advanced NSCLC cases and is a recognized oncogenic driver.

The 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% and 40.6% among treatment-naïve and previously treated patients, respectively, based on BIRC assessment per RECIST. The study demonstrated that capmatinib provided durable responses among all patients.

All results were based on independent assessment by the BIRC (the Blinded Independent Review Committee) and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response, concluded the company.



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