Suresnes (France), 27 th April 2016 – Servier today announced that the European Commission (EC) has granted marketing authorization for LONSURF® (trifluridine/tipiracil), formerly known as TAS-102, in the European Union (EU) in the field of advanced metastatic colorectal cancer. LONSURF is an oral anticancer drug, comprising the combination of trifluridine (FTD) and tipiracil (TPI).
“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.”, said Professor Eric Van Cutsem, MD, PhD, Digestive Oncology, University Hospitals Leuven in Belgium.
“With this approval, we are delivering on a promise to bring a new treatment to patients with advanced metastatic colorectal cancer across Europe,” said Dr. U. Marion Schrenk, Head of Global Medical Strategy, Oncology at Servier. “We are excited about this important milestone, which demonstrates Servier’s commitment to improving the lives of patients living with cancer.”
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.
In June 2015, Servier entered into an exclusive license agreement with Taiho Pharmaceutical Co., Ltd. for the co-development and commercialization of LONSURF. Under the terms of the agreement, Servier has the rights to co-develop and commercialize LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. Taiho Pharmaceutical retains the right to develop and commercialize LONSURF in the United States, Canada, Mexico, and Asia and to manufacture and supply the product.
Servier is an independent research-based pharmaceutical company headquartered in France. With a strong international presence in 148 countries and 92% of its medicines being prescribed outside of France, Servier employs more than 21,200 people worldwide. In 2015, the company recorded a turnover of 3.9 billion euros of which 24% was reinvested in research and development. Currently, there are nine new molecular entities in clinical development for oncology respectively in breast, lung and other solids tumors as well as various leukemias and lymphomas.
This portfolio of innovative cancer treatments is being developed with various partners worldwide, and covers different hallmarks of cancer including cytotoxics, proapoptotic, targeted, immune and cellular therapies.
Servier Communication Department
Tel: +44 203 808 6472/6474