27 April 2016 - Servier today announced that the European Commission has granted marketing authorization for Lonsurf (trifluridine with tipiracil hydrochloride), formerly known as TAS-102, in the European Union for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

Lonsulf is an oral anti-cancer drug, comprising the combination of trifluridine and tipiracil, whose dual mechanism of action is designed to maintain clinical activity.

The decision from the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommending the approval of Lonsulf in February 2016. Both the CHMP opinion and the European Commmission decisions were based on data from the international, double-blind, placebo-controlled Phase III RECOURSE study, which investigated the efficacy and safety of Lonsulf with best supportive care compared to placebo with best supportive care in 800 patients with previously treated mCRC. The study met the primary endpoint of statistically significant improvement in overall survival.

For more details, go to: http://www.servier.com/content/patients-advanced-metastatic-colorectal-cancer-europe-now-have-new-treatment-option-lonsurf®