2024/02/09
Keio University School of Medicine
Keio University Hospital
An investigator-initiated, multicenter clinical trial, "Investigator-Initiated, Multicenter, Phase II Clinical Trial of Anti-PD-1 Antibody Therapy for Epithelial Skin Cancer," led by a group including Associate Professor Ken Funakoshi and Senior Lecturer Yoshio Nakamura from the Department of Dermatology, Keio University School of Medicine, has demonstrated efficacy, with the primary endpoint being the response rate as determined by central review. Based on these results, Ono Pharmaceutical Co., Ltd., the manufacturer and distributor of OPDIVO, submitted an application on June 15, 2023, for a partial change to the manufacturing and marketing approval in Japan for the indication of unresectable advanced or recurrent epithelial skin cancer. Today, this application for a partial change to the manufacturing and marketing approval was approved, leading to regulatory approval.
Please see below for the full press release.