The European Commission (EC) has granted marketing authorisation for Servier’s Lonsurf for the treatment of patients with advanced metastatic colorectal cancer (mCRC)
Lonsurf, formerly known as TAS-102, is an oral anticancer drug, comprising the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity, according to Servier.
Eric Van Cutsem, from the digestive oncology department at the University Hospitals Leuven in Belgium, said: “Data from the pivotal Recourse study provides evidence that Lonsurf may offer patients with refractory mCRC extended survival as well as a reduction in risk of death compared to placebo.
“The combination of trifluridine and tipiracil in Lonsurf works by directly attacking the DNA of the tumour cells which reduces the growth of cancer cells.
“This approach fights the cancer differently to other previously given treatments, allowing us to delay cancer progression rather than cycling back through therapies that have already been used.”
Marion Schrenk, head of global medical strategy, oncology at Servier, said: “With this approval, we are delivering on a promise to bring a new treatment to patients with advanced metastatic colorectal cancer across Europe.”
The decision from the EC follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of Lonsurf in February 2016.
Both the CHMP opinion and the EC decisions were based on data from the international, double-blind, placebo-controlled Phase III Recourse study, which investigated the efficacy and safety of Lonsurf with best supportive care (BSC) compared to placebo with BSC in 800 patients with previously treated mCRC.
The study met the primary endpoint of statistically significant improvement in overall survival (OS), according to Servier.