Taiho Pharmaceutical Co., Ltd. , a subsidiary of Otsuka Holdings Co.., Ltd, has received approval from the Ministry of Health, Labour and Welfare, Japan to manufacture and market the oral combination anticancer drug ''Lonsurf combination tablet T15, T20'' (trifluridine and tipiracil hydrochloride; development code: TAS-102), for the treatment of patients with unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies).

Japan is the first country in the world to grant marketing authorization for Lonsurf. The approval is based primarily on the results of a randomized, double blind placebo controlled phase II clinical trial conducted in Japan (J003-10040030). Taiho is conducting a global phase III clinical trial (RECOURSE) on patients with metastatic colorectal cancer refractory to standard chemotherapies.

Lonsurf is a combination drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme thymidine phosphorylase.

Taiho Pharmaceutical is to make Lonsurf available to physicians in Japan as a new treatment option for patients with metastatic colorectal cancer refractory to standard therapies.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co.., Ltd.., Is an R&D-driven specialty pharmaceutical company focused on three areas of oncology, allergy and immunology, and urology.