First approval in Japan for Keytruda plus Lenvima combo

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the combination of Keytruda (pembrolizumab), Merck Co’s (NYSE: MRK) anti-PD-1 therapy, plus Lenvima Ienvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai (TYO; 4523), for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy.

This approval marks the first time the combination of Keytruda plus Lenvima has been approved in Japan.

“Rates of endometrial carcinoma have been steadily increasing in Japan each year, and there are limited options for patients who are diagnosed at an advanced stage or find their disease has returned,” said Dr Gregory Lubiniecki, vice president, clinical research, Merck Research Laboratories. “With today’s approval, patients in Japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy,” he added.