Merck’s anti PD-1 therapy Keytruda has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) to treat the patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy.
The approval is based on data from the phase 3 trial, which showed superior overall survival (OS) for Keztruda versus investigator-choice chemotherapy.
In the company’s announcement from January 2, chief medical officer, Dr. Roy Baynes explained that chemotherapy has long been the standard of care for advanced urothelial carcinoma, with few options available for patients whose disease progresses.
Dr. Baynes, senior vice president and head of global clinical development, said that approval of Keytruda is entrance of the first anti-PD-1 therapy for these patients in Japan based on the compelling overall survival data from KEYNOTE-045.
With this approval, Keytruda is now indicated for use in four types of cancer in Japan, including for the treatment of radically unresectable melanoma, PD-L1-positive unresectable advanced or recurrent non-small cell lung cancer and relapsed or refractory classical Hodgkin lymphoma, Merck said.
MSD – as Merck is known outside the USA and Canada – will market KEYTRUDA in Japan and will promote it with Taiho Pharmaceutical Co., Ltd.