Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, “tasurgratinib”) for biliary tract cancer with FGFR2 gene fusion. In Japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, (MHLW). Under this system, this application will be subject to priority review.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and MSD K.K. (Headquarters: Tokyo, President: Kyle Tattle, “MSD”), a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., (known as MSD outside the United States and Canada) announced today that Eisai has submitted an application in Japan for the additional indication of its in-house discovered and developed multiple receptor tyrosine kinase inhibitor, LENVIMA® (generic name: lenvatinib mesylate), in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s KEYTRUDA® (generic name: pembrolizumab) as a treatment for patients with advanced renal cell carcinoma (RCC). This is the first application to be submitted in Japan for this combination therapy.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the European Medicines Agency (EMA) has confirmed it has accepted for review applications for the use of its in-house discovered multiple receptor tyrosine kinase inhibitor, lenvatinib mesylate (product name: LENVIMA® / Kisplyx®, “lenvatinib”), in combination with anti-PD-1 therapy pembrolizumab (brand name: KEYTRUDA®), developed by Merck & Co., Inc., Kenilworth, N.J., U.S.A., (known as MSD outside the United States and Canada) as a treatment f or patients with advanced renal cell carcinoma (RCC) and advanced endometrial carcinoma (EC), respectively.