Merck, known as MSD outside the United States and Canada, and Eisai announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of Keytruda.

Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC. This marks the second approval of this combination in Japan; in December 2021, Keytruda plus Lenvima was approved for unresectable, advanced or recurrent endometrial carcinoma that progressed after chemotherapy.

“Nearly one in three cases of renal cell carcinoma are diagnosed at an advanced stage, and patients are in need of new treatment options that may improve survival outcomes,” said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories.

“Today’s milestone for KEYTRUDA plus LENVIMA as a treatment for radically unresectable or metastatic renal cell carcinoma is particularly exciting as it marks the second approval for the combination in Japan,” said Terushige Iike, President of Eisai Japan, Senior Vice President, Eisai.

“We are thrilled to be able to provide Japanese patients with a new treatment option, illustrating our shared commitment with Merck to develop therapies with the aim of addressing the unmet needs of those living with difficult-to-treat cancers. We would like to thank the patients, families and healthcare providers who made this approval possible.”