Posted by Michael Wonder on 03 Jan 2023
Libtayo (cemiplimab) approved in Japan for advanced or recurrent cervical cancer
23 December 2022 - Regeneron Pharmaceuticals today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorisation for Libtayo (cemiplimab) as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy.
The MHLW approval is based on positive data from the international, multi-centre Phase 3 EMPOWER-Cervical 1 trial, conducted in collaboration with NRG Oncology Japan, the GOG Foundation and the European Network for Gynaecological Oncological Trial groups.
