Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co. Ltd., completed its rolling New Drug Application submission to FDA for TAS-102 (trifluridine and tipiracil hydrochloride). TAS-102 is an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer.
TAS-102 was granted Fast Track designation in September 2014, with the first sections of the rolling submission accepted by the FDA on Oct. 16, 2014. The submission is supported by the results from the phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies.
The 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.
TAS-102 is an oral combination investigational anticancer drug of trifluridine and tipiracil hydrochloride. FTD is an antineoplastic 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.
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