Taiho Oncology announced that the Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil HCl) for the treatment of refractory metastatic colorectal cancer (mCRC).
The NDA submission was based upon results from the Phase 3 RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies. The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival vs. placebo (HR=0.68, P<0.0001).
TAS-102 is an oral combination of trifluridine (FTD) and tipiracil hydrochloride (TPI). 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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