Roche/Chugai get recurrent gastric cancer indication for Herceptin in Japan

Chugai Pharmaceutical , a Japanese subsidiary of Swiss drug major Roche (SIX: ROG), has obtained approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional indication of advanced or recurrent gastric cancer overexpressing HER2, not amenable to curative resection for the anti-cancer agent Herceptin ( trastuzumab).

In Japan, Herceptin is currently marketed for the treatment of metastatic breast cancer that overexpresses HER2, and as a postoperative adjuvant chemotherapy in breast cancer that overexpresses HER2.

In March 2010, Chugai filed an application for approval with the MHLW with results from the global Phase III clinical study (ToGA) that included Japan. ToGA was conducted in patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer. In the ToGA study, the chemotherapy arm combining 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.