Taiho Pharma has submitted an application in Europe for its investigational oral colorectal cancer therapy TAS-102.

TAS-102 combines the experimental anticancer drug of trifluridine (FTD), which interferes with DNA function, and tipiracil hydrochloride (TPI), which maintains blood concentration of FTD.

The submission, which comes hot on the heels of a US filing earlier this month, is based on data from the Phase III RECOURSE trial involving 800 patients with metastatic CRC who were unresponsive/intolerant to standard therapies.

The therapy hit primary efficacy goals by significantly improving overall survival versus placebo, and also exhibited a safety profile consistent with that observed in earlier clinical trials, the firm said.