Taiho Oncology, Inc. has finalized its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for its proprietary TAS-102 (trifluridine and tipiracil hydrochloride) for the treatment of refractory metastatic colorectal cancer (mCRC).
“The TAS-102 NDA submission represents a major milestone for the company as we seek FDA approval for our lead product candidate,” Fabio Benedetti, M.D., Taiho Oncology’s Senior Vice President and Chief Medical Officer said in a press release. “If approved by the FDA, TAS-102 could become an important new treatment option for patients with metastatic colorectal cancer whose disease has progressed after treatment with standard therapies.”
According to the American Cancer Society, by the end of 2014 colorectal cancer will be responsible for the death of 50,310 patients in the United States.
Taiho’s investigational TAS-102 is a combined oral formulation of trifluridine (FTD), an antineoplastic nucleoside analog that is incorporated into DNA and interferes with its function, and tipiracil hydrochloride (TPI), an inhibitor of the FTD-degrading enzyme thymidine phosphorylase. As such, TPI is responsible for maintaining the blood concentration of FTD.
Earlier this year, TAS-102 was granted Fast Track designation by the FDA for the treatment of mCRC, which intends to accelerate the development and review of new drugs aimed at treating serious or life-threatening conditions that have the potential to address unmet medical needs. This designation allowed Taiho to initiate the review of their NDA filing by the FDA, which was supported by promising result from the Phase III RECOURSE trial of TAS-102, which evaluated 800 patients suffering from mCRC, whose disease had progressed after or who were intolerant to standard therapies.
This trial met its primary efficacy endpoint of statistically significant improvement in overall survival versus placebo, reducing the risk of mortality by 32% and resulting in a median overall survival of 7.1 months for patients treated with TAS-102 versus 5.3 months for those receiving placebo.
Along with a significant 52% decrease in disease progression, patients treated with TAS-102 presented a disease control rate of 44%, when compared to 16-3% in those treated with placebo.