Otsuka gastric cancer drug Teysuno gets EU approval

Japanese drugmaker Otsuka (4768: JP) says that its subsidiary Taiho Pharmaceutical has received approval from the European Commission for Teysuno (S-1), a novel oral anti-cancer agent indicated for the treatment of adults with advanced gastric cancer when given in combination with cisplatin.

The authorization is applicable to the 27 European Union member states and the three European Economic Area countries. Teysuno will be launched in Europe during the second half of 2011, the companies said. Teysuno was authorized for the treatment of gastric cancer in Japan in 1999. It is also authorized in South Korea, China, Singapore and Taiwan.

A member of the fluoropyrimidine class of anticancer agents, Teysuno is a combination of three pharmacological compounds. The main active substance in Teysuno, tegafur, is a prodrug of a chemical called 5-fluorouracil (5-FU), meaning that it is converted in the body to 5-FU. In the body, 5-FU interferes with the enzymes involved in making DNA. As a result, it can prevent the growth of cancer cells or result in cell death. The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects. Specifically, gimeracil prevents the breakdown of 5-FU and oteracil reduces the activity of 5-FU in normal, non-cancerous tissue in the gut.