Regeneron Gets FDA Priority Review of Libtayo in Advanced Cervical Cancer
28 Septiembre 2021 - 6:50AM
Noticias Dow Jones
By Colin Kellaher
Regeneron Pharmaceuticals Inc. on Tuesday said the U.S. Food and
Drug Administration granted priority review to its application for
expanded use of the cancer drug Libtayo to treat patients with
recurrent or metastatic cervical cancer whose disease progressed on
or after chemotherapy.
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 Jan. 30,
2022.
Regeneron, of Tarrytown, N.Y., and France's Sanofi are jointly
developing and commercializing Libtayo under a global collaboration
agreement.
Regeneron said the FDA is reviewing the application under its
"Project Orbis" initiative, which allows for concurrent review by
health authorities in Australia, Brazil, Canada and Switzerland.
The company said it also plans to file for European Union approval
of the new indication by the end of the year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 28, 2021 07:35 ET (11:35 GMT)
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