News Release


Lonsurf® Combination Tablet for the Treatment of Unresectable Advanced or Recurrent Colorectal Cancer Receives Approval in Japan for Partial Change in Indications (20/03/2015)

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today that Lonsurf® combination anticancer tablet T15, T20 (IND code: TAS-102, nonproprietary names: trifluridine and tipiracil hydrochloride) for the treatment of unresectable advanced or recurrent colorectal cancer received approval on March 20 for a partial change in indications as a result of expedited review by the Japan's Ministry of Health, Labour and Welfare.

In March 2014, Japan became the first country in the world to approve Lonsurf, a new oral nucleoside antitumor agent, for the indication of unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies), based on the results of Phase II clinical trial conducted in Japan. Lonsurf was subsequently launched in Japan in May 2014. A condition stipulated at the time of approval required that the results of a global Phase III trial (RECOURSE) investigating the drug's efficacy and safety be promptly submitted. After submission of these results, the condition that restricted the drug's indications to "only if refractory to standard therapies" was removed, and the indications were then revised to "unresectable advanced or recurrent colorectal cancer."

The RECOURSE trial is a pivotal randomized, double blind, placebo controlled trial conducted in 800 mCRC (metastatic colorectal cancer) patients, whose disease had progressed after or who were intolerant to standard therapies. This 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.

Taiho Pharmaceutical anticipates that this partial revision will allow Lonsurf, as a treatment option, to make an even greater contribution to colorectal cancer patients in Japan.

About Lonsurf
Lonsurf is an oral combination investigational anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated 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. The drug is currently under review by Health Authorities in the United States and Europe.

About Metastatic Colorectal Cancer
In Japan, it is estimated that 128,500 patients (73,200 men and 55,300 women) were diagnosed with, and 49,500 patients (26,600 men and 22,900 women) died of colorectal cancer in 2014. It is also estimated that colorectal cancer was the third most common cause of cancer death in Japan in 2014i.
There are no definitive data on the number of patients who are refractory to standard metastatic colorectal cancer treatments.

i Projected Cancer Statistics 2014, Cancer Information Service


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