TAS 102 filed with FDA for Colorectal Cancer-Taiho Pharma
Taiho Pharma Europe has submitted a Marketing Authorisation Application to the European Medicines Agency for TAS 102 (trifluridine and tipiracil hydrochloride), an oral combination anticancer drug intended for use in the treatment of refractory metastatic Colorectal Cancer (mCRC).
The 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 and demonstrated a safety profile consistent with that observed in earlier clinical trials.
Comment: This submission closely follows the TAS-102 New Drug Application submission to the FDA which was accepted for review by the FDA on February 17, 2015.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.