By Colin Kellaher

 

Regeneron Pharmaceuticals Inc. and Sanofi SA on Friday said they have voluntarily withdrawn their application seeking expanded U.S. approval of the cancer drug Libtayo as a second-line treatment for patients with advanced cervical cancer.

The companies said they made the decision after they weren't able to align with the U.S. Food and Drug Administration on certain post-marketing studies, adding that they are continuing discussions with regulatory authorities outside the U.S.

The FDA in September had granted priority review to the companies' application for expanded use of Libtayo to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy and had set a target action date of Jan. 30.

Tarrytown, N.Y., biotechnology company Regeneron is developing and commercializing Libtayo with France's Sanofi under a global collaboration agreement. The drug is approved in several cancer indications around the world.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

January 28, 2022 07:39 ET (12:39 GMT)

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