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news.Taiho Pharmaceutical and its parent firm Otsuka have said the European Commission (EC) has granted marketing authorization for novel oral anti-cancer agent Teysuno (S-1), indicated for the treatment of adults with advanced gastric cancer when given in combination with cisplatin.
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The EC’s marketing authorization decision was based in part on the results of the First-Line Advanced Gastric Cancer Study (FLAGS), an international Phase III trial conducted in patients with advanced gastric cancer.
Teysuno will be launched in Europe during the second half of 2011.
Teysuno, a member of the fluoropyrimidine class of anticancer agents, is a combination of three pharmacological compounds.
The main active substance tegafur is a prodrug of a chemical called 5-fluorouracil (5-FU), which interferes with the enzymes involved in making DNA.
The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects.
Teysuno was authorized for the treatment of gastric cancer in Japan in 1999.
Teysuno is also authorized for patients with gastric cancer in South Korea, China, Singapore and Taiwan.