Libtayo approved in Japan for advanced or recurrent cervical cancer.- Regeneron Pharma
Regeneron Pharmaceuticals announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Libtayo (cemiplimab) as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy.
"In recent years, the incidence of cervical cancer has increased in Japan, with the prognosis for advanced stage disease remaining poor and treatment options limited," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "With this approval, Libtayo becomes the first single-agent immunotherapy approved in Japan for the treatment of advanced cervical cancer."
The MHLW approval is based on positive data from the international, multicenter Phase III EMPOWER-Cervical 1 trial, conducted in collaboration with NRG Oncology-Japan, the GOG Foundation, Inc., and the European Network for Gynaecological Oncological Trial (ENGOT) groups. The trial evaluated Libtayo compared to an investigator's choice of chemotherapy and enrolled 608 patients across 14 countries, including Japan, irrespective of PD-L1 expression status or histology. In March 2021, the trial was stopped early based on the highly significant effect of Libtayo on overall survival among squamous cell carcinoma patients following a unanimous recommendation by the Independent Data Monitoring Committee.
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