News
Regeneron and Sanofi withdraw Libtayo sBLA from FDA to treat advanced cervical cancer.
Regeneron Pharmaceuticals, Inc. and Sanofi announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.
The decision was made after the companies and the FDA were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the U.S. are ongoing.
Condition: Cervical Cancer
Type: drug
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