Updated on 2 May 2016
The European Commission (EC) has granted marketing authorization for Tokyo's Taiho Pharmaceutical's Lonsurf (trifluridine/tipiracil), formerly known as TAS-102, in the European Union (EU) for the treatment of adult patients with metastatic colorectal cancer (mCRC) 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.
Lonsurf was originally developed by Taiho Pharmaceutical, and Servier will co-develop and commercialize Lonsurf in EU countries under a license agreement with Taiho Pharmaceutical. Servier is an independent research-based pharmaceutical company headquartered in France.
"Data from the pivotal RECOURSE study provides evidence that LONSURF may offer patients with refractory metastatic colorectal cancer extended survival as well as a reduction in risk of death compared to placebo," said Professor Eric Van Cutsem, MD, PhD, Digestive Oncology, University Hospitals Leuven in Belgium. "The combination of trifluridine and tipiracil in Lonsurf works by directly attacking the DNA of the tumor 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."
The company explained that the decision from 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 decision 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).