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Merck Reports Approval Of KEYTRUDA For Urothelial Carcinoma In Japan

Merck (MRK) 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 for KEYTRUDA versus investigator-choice chemotherapy. With the approval, KEYTRUDA is now indicated for use in four types of cancer in Japan.

Merck said it will market KEYTRUDA in Japan and will promote it with Taiho Pharmaceutical Co., Ltd.

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