Taiho Pharmaceutical Co. Ltd. announced last week that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended LONSURF for the treatment of metastatic colorectal cancer (mCRC) in adults.
LONSURF was developed by Taiho and was presented by Servier for marketing authorization in European countries in accordance with a licensure agreement with Taiho.
LONSURF, previously known as TAS-102, was developed to treat adults with mCRC who have received prior treatments, or are not candidates for, chemotherapies that use fluoropyrimidine, oxaliplatin and irinotecan, anti-VEGF agents and anti-EGFR agents.
The recommendation by the CHMP was due to data collected from a double-blind, placebo-controlled Phase 3 study known as RECOURSE. The study researched the safety and efficiency of LONSURF with best support care (BSC) in the 800 patients who participated in the trial and who had previously received mCRC treatment. The trial was successful in meeting its primary goal, which was the vast improvement of overall survival (OS).
The next step in the process is for LONSURF to be reviewed by the European Commission. If it receives marketing authorization, LONSURF will be authorized in 28 countries that are members of the European Union, and also Iceland, Lichtenstein and Norway.