The Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMA), has issued a positive 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.

With an estimated 934,000 new cases per year (8.6% of all new cancer cases), gastric cancer is the fourth most common cancer worldwide, following lung, breast, and colorectal cancers.[1] It is the second most common cause of cancer-related death, accounting for an estimated 700,000 to 800,000 deaths annually.[1,2] Nearly 70% of new cases occur in developing countries; 42% of new cases occur in China alone.[1,2]

In Europe, gastric cancer is the seventh most common cancer and the sixth most common cause of cancer death, with an estimated annual mortality rate of 118,200.[3] In general, gastric cancer incidence rates are about twice as high among men as in women. The disease is difficult to cure unless it is diagnosed in its early stages. Unfortunately, because early gastric cancer causes few symptoms, the disease is not usually diagnosed until it has reached an advanced stage. In Europe, the five-year survival rate for gastric cancer is roughly 20% in men and 25% in women. Similarly, in the United States, the five-year survival rate for gastric cancer is 24%, though survival rates improve to 61% if the disease is detected early. However, less than one-quarter of gastric cancers are diagnosed at an early stage in the United States.[2] In contrast, the five-year survival rate exceeds 50% in Japan, where early gastric cancer is diagnosed relatively frequently due to mass screening efforts, which have been practiced since the 1960s.[1,2]

“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.

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“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.”

On the basis of quality, safety and efficacy data submitted, the CHMP considered that there is 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.

Teysuno was designated an orphan medicinal product by the EMA in 2007 in recognition of its development specifically to treat the rare condition of gastric cancer. Since its initial approval in Japan in 1999, Teysuno has become a standard of care there for the treatment of gastric cancer. Teysuno is also approved for patients with gastric cancer in South Korea, China, Singapore and Taiwan. Teysuno was subsequently approved in Japan for six additional indications: for the treatment of colorectal, head and neck, non-small cell lung, metastatic breast, pancreatic and biliary tract cancers. To date, Teysuno has been used by more than 870,000 patients in Japan and Asia.

For more information
[1] Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.
[2] Garcia M, Jemal A, Ward EM, et al. Global Cancer Facts & Figures 2007. Atlanta, GA: American Cancer Society, 2007
[3] Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007;18:581?59.

Summary of opinion (initial authorisation in Europe)

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