News Releases

September 24, 2015
Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical Announces FDA Approval of LONSURF® (trifluridine and tipiracil) for Refractory Metastatic Colorectal Cancer (mCRC)

Approval provides patients with new therapeutic option for mCRC that is refractory or intolerant to standard chemotherapies

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) today announced that the U.S. Food and Drug Administration (FDA) approved LONSURF® (nonproprietary names: trifluridine and tipiracil, IND code:TAS-102) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

LONSURF is the first FDA–approved product for the company, and Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd., will market LONSURF in the United States.

The FDA approval of LONSURF is based on results from the global Phase III RECOURSE trial that is a pivotal randomized, double blind, placebo controlled trial conducted in 800 patients who have been previously treated for mCRC. The trial met the primary efficacy endpoint of statistically significant improvement in overall survival compared to placebo (HR = 0.68, p < 0.001) and demonstrated a safety profile consistent with that observed in earlier clinical trials.i


LONSURF is an oral combination anticancer drug of trifluridine (FTD) and tipiracil (TPI). FTD is an antineoplastic thymidine-based 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. LONSURF was approved initially in Japan in March 2014 based on the results of the Phase II clinical trial conducted in Japan, and launched in Japan in May 2014.

About Colorectal cancer

Colorectal cancer is the third most common type of cancer and is the second leading cause of cancer-related deaths in the U.S.ii In the U.S., there were an estimated 136,830 patients diagnosed with cancer of the colon or rectum in 2014, and in 2012, there were an estimated 1.1 million individuals living with the disease.iii,iv Of those, about 27,400 patients will have had their cancer spread to another part of the body.iv

i Mayer RF, Cutsem EV, Falcone A, et al.; Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer. N Engl J Med. 2015; 372:1909-1919

ii American Cancer Society; What are the key statistics about colorectal cancer? Accessed August 2015.

iii American Cancer Society; Cancer Facts & Figures 2014. Accessed September 2015.

iv National Cancer Institute; Surveillance, Epidemiology, and End results Program Fact Sheet: Colon and Rectum. Accessed September 2015.

Information in this news release was current as of the original release date.

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