Taiho Pharmaceutical Co., Ltd., and its parent company, Otsuka Holdings Co., Ltd., announced that the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMA), has issued an opinion recommending approval of Teysuno™ (S-1), a novel oral anti-cancer agent, intended for the treatment of advanced gastric cancer in adults when given in combination with cisplatin.
The Committee will now recommend that the European Commission (EC) grant marketing authorization for Teysuno, a decision that is normally issued within 67 days from adoption of a CHMP opinion.
“We are pleased with the CHMP’s positive opinion on Teysuno. It is an important step toward a new treatment option for European adults living with gastric cancer,” said Toru Usami, President, Taiho Pharmaceutical Co., Ltd.
“The CHMP recommendation also represents the first regulatory milestone for Taiho outside of Japan and Asia. Teysuno is the first of what we hope will be many promising anti-cancer agents to be developed globally and made commercially available by Taiho.”
A member of the fluoropyrimidine class of chemotherapeutic agents, Teysuno is a combination of three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption, is converted into the anti-cancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU by the body; and oteracil (Oxo), which decreases 5-FU activation in the gastrointestinal tract.
The Committee’s recommendation 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.
“In the FLAGS study, a Teysuno containing regimen was as effective as the comparator with a favorable safety profile,” commented Fabio M. Benedetti, M.D., Chief Medical Officer of Taiho Pharma U.S.A., Inc. “Availability of Teysuno in Europe will provide physicians with another option in the management of this very difficult to treat disease.”
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Teysuno and therefore recommends granting marketing authorization for the product. The CHMP recommendation requires formal approval by the EC for marketing of Teysuno in all European Union (EU) Member States, which is expected in early 2011.
Taiho is currently in discussions with potential marketing partners for Teysuno to ensure its timely and effective introduction to the European oncology community.
Source: Taiho Pharmaceutical Co., Ltd