Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

Taiho Pharma Europe, a subsidiary of Japanese drugmaker Otsuka (TYO: 4768), has submitted a marketing authorization application to the European Medicines Agency for TAS-102 (trifluridine and tipiracil hydrochloride) for refractory metastatic colorectal cancer.

This submission comes soon after the New Drug Application submitted to the US Food and Drug Administration, which was accepted for review by the FDA on February 17, 2015. The submission is supported by the results of the randomized, double-blind, placebo-controlled Phase III RECOURSE trial in 800 patients whose disease had progressed after, or who were intolerant to, standard therapies. It met the primary efficacy endpoint of statistically-significant improvement in overall survival versus placebo and demonstrated a safety profile consistent with that observed in other clinical trials.

Eric Benn, director of Taiho Pharma Europe, said: “Submission of the TAS-102 Marketing Authorisation Application to the European Medicines Agency is a significant milestone for the company. It exemplifies our commitment to delivering novel cancer treatment options to patients and physicians. We look forward to working with the EMA as it conducts its review of TAS-102.”