Regeneron Gets FDA Priority Review of Libtayo in Advanced Cervical Cancer

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 [e-mail]

(END) Dow Jones Newswires

September 28, 2021 07:35 ET (11:35 GMT)

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