Incyte's (INCY) Capmatinib NDA Gets Priority Review From FDA
Zacks Investment Research | Feb 10, 2020 09:04PM ET
Incyte Corporation (NASDAQ:INCY) announced that the FDAaccepted and granted Priority Review to the new drug application (NDA) for capmatinib, which is an investigational, oral selective MET inhibitor. The company is seeking approval of capmatinib for the treatment of first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC) — a type of lung cancer with a particularly poor prognosis. If approved, the candidate will be the first therapy to specifically target METex14 mutated advanced lung cancer.
The Priority Review designation from the FDA is generally granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to 10 months for standard review.
Shares of the company have lost 7.7% in the past year compared with the Zacks Investment Research
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