Taiho submits TAS-102 Marketing Authorisation Application to the European Medicines Agency for the treatment of refractory metastatic colorectal cancer

Taiho Pharma Europe Ltd., a subsidiary of Japan based Taiho Pharmaceutical Co., Ltd., announced that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer (mCRC).

Taiho Pharma Europe Ltd.’s TAS-102 MAA submission closely follows the TAS-102 New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which was accepted for review by the FDA on February 17, 2015.

“Submission of the TAS-102 Marketing Authorisation Application to the European Medicines Agency is a significant milestone for the company,” said Eric Benn, Director of Taiho Pharma Europe Ltd. “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.”

Taiho Pharma Europe Ltd.’s MAA submission is supported by the results of the 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 TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.0001) and demonstrated a safety profile consistent with that observed in earlier clinical trials.

“Metastatic colorectal cancer is one of the top causes of morbidity and mortality in European men and women who are suffering with cancer,” said Professor Eric Van Cutsem, MD, PhD, Professor of Medicine at the University of Leuven and Head of Digestive Oncology at the University Hospitals of Leuven, Belgium and principal investigator of the RECOURSE study. “If authorised, TAS-102 has the potential to become an important new treatment option for patients within the European Union who are living with refractory metastatic colorectal cancer.”