Novartis, Incyte: Capmatinib Gets FDA Priority Review
February 11 2020 - 6:43AM
Dow Jones News
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.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 11, 2020 06:28 ET (11:28 GMT)
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