EC grants marketing authorization for Taiho's Teysuno to treat gastric cancer

Taiho Pharmaceutical Co., Ltd., and its parent company, Otsuka Holdings Co., Ltd., announced today that the European Commission (EC) has granted marketing authorization 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 Member States and the three European Economic Area (EEA) countries of the European Union (EU).

"For European patients living with gastric cancer, the availability of this new treatment option is a timely addition to the therapeutic landscape," said Alfredo Carrato, MD, Professor and Director of the Medical Oncology Department at Ramon y Cajal University Hospital in Madrid, Spain.

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.

The EC's marketing authorization decision was based in part on the results of the First-Line Advanced Gastric Cancer Study (FLAGS), the largest international Phase III trial ever conducted in patients with advanced gastric cancer.

"We are pleased that the European Commission has recognized the importance of the FLAGS study findings, which showed that Teysuno-based combination therapy was as effective as a comparator regimen, with an acceptable safety profile," commented Fabio M. Benedetti, MD, Chief Medical Officer of Taiho Pharma U.S.A., Inc.

Teysuno™ will be launched in Europe during the second half of 2011.