News Releases

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride, brand name in Japan ''Lonsurf^® combination tablet T15, T20''), an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC), and that the Company has initiated a rolling NDA submission to the FDA.

The FDA established the Fast Track designation process to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs are afforded a rolling review of their New Drug Application (NDA) filing by the FDA.

The results from the Phase III RECOURSE trial of TAS-102 in 800 patients affected with mCRC, whose disease had progressed after or who were intolerant to standard therapies, are the foundation for Taiho's NDA submission to the FDA. Taiho expects to complete its submission by the end of this year.

TAS-102 is an oral combination anticancer 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. TAS-102 was approved initially in Japan in March this year for the indications of ''unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies),'' based on the results of the Phase II clinical trial conducted in Japan, and launched in Japan in May under the brand name ''Lonsurf® combination tablet T15, T20''.

Colorectal cancer is the third most common cancer worldwide. In 2014, it is estimated that 136,830 patients (71,830 men and 65,000 women) will be diagnosed with, and 50,310 patients will die from, cancer of the colon or rectum in the United States.ⁱ Colorectal cancer was the second most common cancer in Europe in 2012. In addition, it was estimated that 447,000 patients (242,000 men and 205,000 women) were diagnosed with and 215,000 patients died of colorectal cancer in Europe during 2012.ⁱⁱ
There are no definitive data on the number of patients who are refractory to standard metastatic colorectal cancer treatments.

i Cancer facts & figures 2014. American Cancer Society.
ii Ferlay, J. et. al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. European Journal of Cancer. 49; 1374-1403.