Merck announced that KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy, has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy. The approval is based on data from the phase 3 KEYNOTE-045 trial, which demonstrated superior overall survival (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI, 0.59, 0.91], p=0.002). 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. MSD will market KEYTRUDA in Japan and will promote it with Taiho Pharmaceutical Co. Ltd.