Chugai Pharmaceutical Co, Ltd announced that it filed an application with the Japanese Ministry of Health, Labour and Welfare, seeking additional approval of combination therapy with trastuzumab (genetical recombination), a humanized monoclonal antibody (brand name: Herceptin for Intravenous Infusion 60 and 150) and capecitabine, an oral fluoropyrimidine anti-cancer agent (brand name: Xeloda Tablet 300 mg), for the treatment of HER2-positive advanced or recurrent gastric cancer.
In the global phase-III clinical study (ToGA) conducted for patients with HER2-positive advanced or recurrent gastric cancer, the chemotherapy arm combined with fluoropyrimidine anti-cancer agent (Xeloda or intravenous 5-FU) and cisplatin, and the treatment arm adding Herceptin to this chemotherapy, were compared. The addition of Herceptin to Xeloda or intravenous 5-FU and cisplatin regimen significantly improved overall survival. The safety profile was consistent with the previous reports related to Herceptin or combination chemotherapy, and both arms were well tolerated.
Regarding the indication of Herceptin for HER2-positive metastatic gastric cancer in other countries, F. Hoffmann-La Roche Ltd. filed the application to expand market approval with the European Medicines Agency in September, 2009 and obtained approval in January this year.
Gastric cancer is prevalent in Asian countries including Japan, South Korea and China as well as in South America. In Japan, gastric cancer is the second highest causal factor among the cancer types that led to deaths (second in male, third in female). It is estimated that here will be approximately 110,000 new patients in 2010.
Chugai positions Oncology as one of its key therapeutic areas, and will prepare for the approval to offer medical practitioners and patients a new treatment option as soon as possible.