Sanofi’s LIBTAYO, Cemiplimab IV, was approved in December 2022
based on results of global Ph 3 EMPOWER-Cervical 1 study, of which duration was around 6 years. This is the 3rd approval for PD-1 inhibitor in Japan following Opdivo and Keytruda. It was approved to treat patients with advanced or recurrent cervical cancer whose diseases progressed after chemotherapy, and that means Keytruda has been already approved for advanced or recurrent cervical cancer in Japan.
While precedent Opdivo and Keytruda have been approved for wide indications, LIBTAYO’s future positioning and strategic challenges to compete with 2 giants would become a big topic in Japan.
Reference:
Study of Cemiplimab in Adults With Cervical Cancer – Full Text View – ClinicalTrials.gov