Taiho Oncology, Inc, announced that the FDA granted Fast Track designation for an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer.
the United States
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (), announced that the FDA granted Fast Track designation for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC), and that the company has initiated a rolling New Drug Application (NDA) submission to the FDA. According to the American Cancer Society, an estimated 136,830 people will be diagnosed with, and 50,310 people will die from, cancer of the colon or rectum during 2014 in .
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 NDA filing by the FDA.