News Release


Taiho Pharmaceutical Announces TAS-102 (brand name in Japan: "Lonsurf®") New Drug Application for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA (23/02/2015)

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission of a New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride, brand name in Japan: "Lonsurf® combination tablet T15, T20"). TAS-102 is an oral combination investigational anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC). The PDUFA goal date is December 19, 2015.

Results from the Phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies, form the foundation for the NDA. The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.0001) and demonstrated a safety profile consistent with that observed in earlier clinical trials.

About TAS-102
TAS-102 is an oral combination investigational 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 2014 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 2014 under the brand name "Lonsurf® combination tablet T15, T20".

About Refractory Metastatic Colorectal Cancer
There are no definitive data on the number of patients who are refractory to standard metastatic colorectal cancer treatments; however, colorectal cancer is the third most common cancer worldwide. In 2014, it was estimated that 136,830 patients (71,830 men and 65,000 women) would be diagnosed with, and 50,310 patients would 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

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.

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