The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Taiho Oncology’s TAS-102 (trifluridine/tipiracil hydrochloride) for the treatment of refractory metastatic colorectal cancer (mCRC).
The Fast Track designation is intended 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. Furthermore, if a drug receives this designation, it can initiate a review of their Drug Application (NDA) filing by the FDA.
In 2014, approximately 136,830 people will be diagnosed with colorectal cancer in the U.S., and an estimated 50,310 people will die from the disease, according to the American Cancer Society.
Taiho’s investigational TAS-102 is a combined oral formulation of trifluridine (FTD), an antineoplastic nucleoside analog which 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 approved in Japan for the treatment of’ unresectable advanced or recurrent colorectal cancer that did not respond to standard therapies. The results of a Phase II clinical trial named “Lonsurf® combination tablet T15, T20” were behind such approval.
The promising results from the Phase III RECOURSE trial of TAS-102, evaluating 800 patients suffering from mCRC whose disease had progressed after or who were intolerant to standard therapies, led to Taiho’s NDA submission to the FDA.
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.
“We are pleased that TAS-102 has been granted Fast Track designation,” Fabio Benedetti, senior vice president and chief medical officer at Taiho Oncology said in a company’s press release. “Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have limited treatment options to manage their disease. We have initiated our rolling NDA submission to the FDA, and are committed to submitting the rest of the filing as efficiently as possible.”