Taiho Pharmaceutical obtains approval in Japan for anticancer drug Lonsurf

Taiho Pharmaceutical Co., Ltd. (Tokyo, President: Masayuki Kobayashi) announced on March 24 that it has obtained approval in Japan from the Ministry of Health, Labour and Welfare to manufacture and market the oral combination anticancer drug "Lonsurf(R) combination tablet T15, T20" (nonproprietary names: 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 is proud to make Lonsurf available to physicians in Japan as a new treatment option for patients with metastatic colorectal cancer refractory to standard therapies.