Regeneron (REGN) Announces Libtayo Approved in Japan for Advanced or Recurrent Cervical Cancer

Regeneron Pharmaceuticals (NASDAQ: REGN) today 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 3 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.

"With Libtayo, Japan now has an approved treatment option that has demonstrated significant survival benefits in this cervical cancer patient population compared to chemotherapy irrespective of PD-L1 expression – a milestone no other PD-1 inhibitor has achieved in a Phase 3 trial," said Prof. Kosei Hasegawa, Gynecologic Oncology, Saitama Medical University International medical Center, a trial investigator and a member of NRG Oncology-Japan. "We are proud to have contributed to bringing this new treatment option to women living with this difficult-to-treat cancer in Japan.

Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed in women between the ages of 35 and 44. Almost all cases of cervical cancer are caused by human papillomavirus (HPV) infection. It is estimated that approximately 600,000 new cases of cervical cancer are diagnosed and 350,000 deaths from cervical cancer occur worldwide each year.

In November 2022, Libtayo was approved by the European Commission for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

You May Also Be Interested In

• Regeneron (REGN): EYLEA HD Injection 8 mg Data at EURETINA Reinforce Long-term Durability, Sustained Fluid Control and Safety Profile
• BridgeBio Pharma (BBIO) Reports Topline Results from Phase 1/2 Trial of Investigational Gene Therapy
• AbbVie's (ABBV) Allergan Aesthetics Launches BOTOX Cosmetic for Masseter Muscle Prominence in Adults in China