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news.Taiho Pharmaceutical has submitted an application to the Japanese Ministry of Health, Labor and Welfare for the manufacturing and marketing approval for its novel oral nucleoside antitumor agent TAS-102 (combination of trifluorothymidine (FTD) and tipiracil hydrochloride (TPI) ).
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Taiho is seeking approval of TAS-102 for the indication of unresectable, advanced, recurrent colorectal cancer.
The application is based on the results of a Phase II clinical trial (Study 10040030) conducted at 20 facilities throughout Japan.
The study, which contained at least two or more regimens containing fluoropyrimidine, irinotecan, and oxaliplatin, was a randomized, double-blind comparative process of TAS-102 and a placebo involving 172 patients with unresectable, advanced, recurrent colorectal cancer, which was refractory to the standard chemotherapy.
The results obtained from the study showed that the group administered TAS-102 had improved overall survival rates (median overall survival: 9 months compared to 6.6 months) and an importantly reduced risk of mortality (HR: 0.56, p=0.0011).
The most frequently reported adverse drug reaction with a CTCAE grade of 3 or higher was neutropenia. Grade 3 or higher diarrhea, fatigue, nausea, and other adverse reactions were no more than 10%.
Taiho is currently continuing with a global Phase III clinical trial of TAS-102 in a similar colorectal cancer population (RECOURSE) with the ultimate goal of global registration and commercialization of the agent.
The firm is hoping that TAS-102 will make an important contribution to cancer patients and will continue its development efforts to widen its use.