Taiho Pharmaceutical, a subsidiary of Japanese drugmaker Otsuka, says that its partner, privately-held French drugmaker Servier, has received approval from the European Commission, of Lonsurf (trifluridine/tipiracil) in combination with bevacizumab.
The authorization is for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have received two prior anti-cancer treatments including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.
The approval by the European Commission is supported by data from the Phase III SUNLIGHT trial for patients suffering from an advanced colorectal cancer who have already failed two prior chemotherapy regimens.
The marketing authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway.
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