Otsuka, Sumitomo Dainippon backed Taiho files for EMA marketing authorization for colorectal cancer candidate

SINGAPORE--Taiho Pharma Europe Ltd., a subsidiary of Japan based Taiho Pharmaceutical Co., Ltd., has submitted a Marketing Authorization Application to the European Medicines Agency for TAS-102, an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer.

Taiho, a subsidiary of Otsuka, and Sumitomo Dainippon Pharma, said March 2 in a release that the candidate, trifluridine and tipiracil hydrochloride. was a "a significant milestone for the company" and follows a randomized, double blind, placebo controlled, Phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies.

The trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo. The EMA filing follows the TAS-102 New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) accepted for review on Feb. 17.

- read the release