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TAS-102 Receives FDA Fast Track Designation for Refractory Metastatic Colorectal Cancer

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The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Taiho Oncology’s TAS-102, a novel agent currently under investigation for the treatment of refractory metastatic colorectal cancer. TAS-102 is an oral combination investigational anticancer drug consisting of trifluridine and tipiracil hydrochloride.

Taiho Oncology has initiated a rolling New Drug Application submission to the FDA based on the results of the phase III RECOURSE trial of TAS-102 in 800 patients whose metastatic colorectal cancer is refractory to standard therapies.

The FDA established the Fast Track designation process to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs are afforded a rolling review of their New Drug Application filing by the FDA.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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