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Taiho Pharmaceutical Co., Ltd. today announced that Health Canada, a Canadian healthcare authority, approved LONSURF^® (trifluridine/tipiracil) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.

LONSURF is the first Health Canada–approved product for Taiho Group, and Taiho Pharma Canada, Inc., a subsidiary of Taiho Pharmaceutical, will market LONSURF in Canada.

The Health Canada approval of LONSURF is based on results from the global Phase III RECOURSE trial 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. ¹

Colorectal cancer is the second most commonly diagnosed cancer in Canada (excluding non-melanoma skin cancers), and is the second leading cause of death from cancer in men and the third leading cause of death from cancer in women. It is estimated that in 2017, 26,800 patients in Canada were diagnosed with colorectal cancer (this represents 13% of all new cancer cases in 2017), and 9,400 Canadians died from colorectal cancer (this represents 12% of all cancer deaths in 2017). On average, an estimated 73 Canadians were diagnosed with colorectal cancer every day, and an estimated 26 Canadians died from colorectal cancer every day. There are no definitive data on the number of patients who are refractory to standard mCRC treatments.

LONSURF is an oral anticancer drug, comprising the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines.

FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the 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.

In Japan, Taiho Pharmaceutical markets LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer. In the United States, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, markets the drug for the treatment of patients with 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.

In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF. Under the terms of the agreement, Servier has the rights to co-develop and commercialize LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside Japan, Jeil Pharmaceutical and TTY Biopharm, which are Taiho Pharmaceutical’s business partners in South Korea and Taiwan, respectively, are preparing to bring the drug to market.

As of February 2018, the drug has been approved as a treatment for advanced mCRC in 44 countries and regions worldwide.

¹ Robert J. Mayer, M.D., et al for the RECOURSE Study Group. Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer. N Engl J Med 2015;372:1909-19. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1414325 Accessed February 2018.

² Canadian Cancer Society. Colorectal cancer statistics. http://www.cancer.ca/en/cancer-information/cancer-type/colorectal/statistics/?region=on Accessed February 2018.