Regeneron gets Libtayo approval in Japan for advanced cervical cancer

Regeneron Pharmaceuticals has secured the approval of the Japanese Ministry of Health, Labor and Welfare (MHLW) to manufacture and market the company’s Libtayo (cemiplimab) for advanced or recurrent cervical cancer.

Libtayo is a type of immunotherapy intended for the treatment of patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy.

The approval of MHLW is backed by the positive findings from the EMPOWER-Cervical 1 phase 3 trial, in which Libtayo showed significant survival benefits in cervical cancer patients compared to chemotherapy irrespective of PD-L1 expression.

The international and multi-center trial enrolled 608 patients across 14 countries, including Japan.

Israel Lowy — Regeneron Pharmaceuticals Oncology Translational and Clinical Sciences Senior Vice President, said: “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.

“With this approval, Libtayo becomes the first single-agent immunotherapy approved in Japan for the treatment of advanced cervical cancer.”

The phase 3 EMPOWER-Cervical 1 clinical trial was conducted in association with NRG Oncology-Japan, the GOG Foundation, and the European Network for Gynaecological Oncological Trial (ENGOT) groups.

Professor Kosei Hasegawa — NRG Oncology-Japan member and one of trial investigators, said: “We are proud to have contributed to bringing this new treatment option to women living with this difficult-to-treat cancer in Japan.”

Libtayo is indicated for advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer in the US and other countries while for advanced cervical cancer in Japan, the EU, Canada and Brazil.

Jointly developed by Sanofi and Regeneron Pharmaceuticals, Libtayo is currently marketed in Japan by the former on behalf of the latter over the course of a defined transition period.

Regeneron Pharmaceuticals is responsible for the development and marketing of Libtayo globally as of 1 July 2022.