LONSURF demonstrated 2-month improvement in median overall survival (OS) compared to placebo in patients with advanced metastatic colorectal cancer (mCRC)1,2 an important benefit in a disease with a 5-year survival rate of only 11% at diagnosis.3
Servier announced that the European Commission (EC) has granted marketing authorisation for 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 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.
“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 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.”
“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. LONSURF has also been shown to prolong progression-free survival and preserve performance status, allowing patients to make time for more moments that matter.”
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 2016.4 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).1,2,5