By Colin Kellaher
Novartis AG (NOVN.EB, NVS) and Incyte Corp. (INCY) Tuesday said the U.S. Food and Drug Administration accepted and granted priority review to a new drug application for capmatinib in a form of non-small cell lung cancer.
The companies said the filing covers capmatinib as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping mutated non-small cell lung cancer.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.
Novartis and Incyte said capmatinib, if approved, would be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis.
Incyte, a Wilmington, Del., biopharmaceutical company, discovered capmatinib and in 2009 granted Swiss drug maker Novartis exclusive worldwide development and commercialization rights to the compound in all indications.
Incyte said it could be eligible for more than $500 million in milestone payments, along with royalties on global sales, if Novartis successfully develops capmatinib.
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