Regeneron Gets FDA Priority Review of Libtayo in Lung Cancer
October 29 2020 - 8:10AM
Dow Jones News
By Colin Kellaher
Regeneron Pharmaceuticals Inc. on Thursday said the U.S. Food
and Drug Administration granted priority review to its application
for expanded use of Libtayo in a form of lung cancer.
The Tarrytown, N.Y., biotechnology company said the application
covers the treatment of patients with first-line locally advanced
or metastatic non-small-cell lung cancer with programmed
death-ligand 1, or PD-L1, expression of 50% or greater.
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.
Regeneron said the agency set a target action date of Feb. 28,
2021, for the application.
Regeneron said the European Medicines Agency is also assessing
Libtayo in the indication, with a decision expected in the second
quarter of 2021.
Libtayo, which Regeneron is jointly developing and
commercializing with France's Sanofi SA, is approved in the U.S.
and European Union for adults with cutaneous squamous-cell
carcinoma.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 29, 2020 07:55 ET (11:55 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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