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The Food and Drug Administration has granted the Fast Track designation to TAS-102 (trifluridine and tipiracil hydrochloride) for the treatment of patients with refractory metastatic colorectal cancer. The oral combination drug, marketed by Taiho Oncology, is an antineoplastic nucleoside analog that is directly incorporated into DNA and interferes with its functioning.

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The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application (NDA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.


The NDA submission for TAS-102 will be based on data from the Phase III RECOURSE trial of the drug in 800 patients with refractory metastatic colorectal cancer. According to data presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer, for patients treated with TAS-102, progression-free survival was two months versus 1.7 months for patients taking the placebo, and overall response rates were 1.6 versus 0.4 percent, respectively (OT 10/10/14 issue). In addition, disease-control rates were 44 percent for patients taking TAS-102 versus 16.3 percent for patients taking the placebo.