Taiho Pharma files for approval of cancer drug TAS-102 in Japan

27 February 2013

Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka (TYO: 4768) says that it submitted an application for approval of the manufacture and marketing of the novel oral nucleoside antitumor agent TAS-102 (combination of trifluorothymidine [FTD] and tipiracil hydrochloride [TPI]) to the Japanese Ministry of Health, Labor and Welfare. Taiho Pharmaceutical is seeking approval of TAS-102 for the treatment 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. It was a randomized, double-blind comparative study of TAS-102 and a placebo involving 172 patients with unresectable, advanced, recurrent colorectal cancer that was refractory to the standard chemotherapy of at least two or more regimens containing fluoropyrimidine, irinotecan, and oxaliplatin.

Drug demonstrated improved overall survival

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