Taiho Oncology announced that the FDA has granted Fast Track designation for trifluridine and tipiracil hydrochloride (TAS-102), an oral combination anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC).
Taiho Oncology has initiated a rolling New Drug Application (NDA) submission to the FDA for TAS-102. The NDA submission was based on a Phase 3 RECOURSE trial of TAS-102 in 800 patients affected with mCRC, whose disease had progressed after or who were intolerant to standard therapies.
Trifluridine is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of trifluridine is maintained via tipiracil hydrochloride, which is an inhibitor of the trifluridine-degrading enzyme, thymidine phosphorylase.
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