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On September 28, 2021, Regeneron announced that the US FDA has granted priority to the supplementary biological product license application (sBLA) for the PD-1 inhibitor Libtayo (cemiplimab) jointly developed by the company and Sanofi.
Cervical cancer is the fourth leading cause of cancer deaths in women in the world, and it most often occurs in women aged 35-44
Libtayo is a PD-1 inhibitor jointly developed by Sanofi and Regeneron
This application is based on the support of the results of a phase 3 clinical trial.
The FDA is expected to respond to this application before January 30, 2022
Reference materials:
[1] FDA Accepts Libtayo® (cemiplimab-rwlc) for Priority Review for Advanced Cervical Cancer.