EMA approves Lonsurf (trifluridine/tipiracil) for metastatic colorectal cancer- Taiho Pharmaceutical/Servier

The European Commission (EC) has granted marketing authorization for Lonsurf (trifluridine/tipiracil), formerly known as TAS-102, from Taiho Pharmaceutical Co, in the European Union 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. Servier will co-develop and commercialize Lonsurf in EU countries under a license agreement with Taiho Pharmaceutical.

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 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. The most frequently observed side effects (greater than or equal to 30%) in patients receiving Lonsurf were neutropenia, nausea, decreased appetite, diarrhea, fatigue, anemia, thrombocytopenia, increase in total bilirubin, alkaline phosphatase and ASAT levels, and leucopenia.

Comment: Lonsurf is currently available in Japan for the treatment of unresectable advanced or recurrent CRC and in the United States for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine -, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy.

Comment: Servier Laboratories have the European rights to Lonsurf.