Health Canada approves first targeted biological therapy to show survival benefit in stomach cancer

Roche announced today that after priority review, Health Canada has approved HERCEPTIN(R) (trastuzumab), in combination with XELODA(R) (capecitabine) or intravenous 5-fluorouracil and cisplatin, for the first-line treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach (gastric cancer) or gastro-esophageal cancer. This approval will drive a significant change in the treatment of this devastating disease, allowing patients with stomach cancer to benefit from this life-extending treatment.

The approval is based on the results from the international ToGA trial, which showed that HERCEPTIN significantly prolongs the lives of patients with this aggressive cancer without compromising quality of life. HERCEPTIN is the first targeted biological therapy to show a survival benefit in advanced stomach cancer. In patients with high levels of HER2 expression, the overall survival was 16 months in the group receiving HERCEPTIN versus 11.8 months (on average) for patients receiving chemotherapy alone.

"As the first biological therapy to show a significant overall survival benefit in advanced stomach cancer, HERCEPTIN represents a new therapeutic option beyond chemotherapy for Canadians living with this horrible disease," said Dr. Christine Brezden-Masley, Staff Medical Oncologist, St. Michael's Hospital and Assistant Professor, University of Toronto Clinical Leader, Oncology Clinical Research Group. "The approval of HERCEPTIN for HER2-positive metastatic stomach cancer provides a much-needed therapeutic alternative which is generally well-tolerated and does not compromise quality of life."

Advanced stomach cancer is associated with a poor prognosis; the median survival time after diagnosis is approximately 10 to 11 months with currently available therapies. Approximately 15 to 19 per cent of stomach tumours show high levels of HER2.

"The approval of HERCEPTIN for patients with advanced stomach or esophageal cancer represents a significant advance in personalized medicine," said Dr. Catherine Streutker, Director of Surgical Pathology, Department of Laboratory Medicine, St. Michael's Hospital and Assistant Professor, University of Toronto. "HER2 testing these patients enables physicians to quickly optimize treatment outcomes, as it allows healthcare resources to be directed towards those patients who are most likely to benefit from HERCEPTIN, while those who are not can be redirected to other treatment options."

Stomach cancer is the second most common cause of cancer-related death in the world and is the fourth most commonly diagnosed cancer. According to the Canadian Cancer Society, in 2010 there will be 2,900 new cases of stomach cancer and 1,850 Canadians will die from the disease. The highest estimated rates of incidence of stomach cancer for 2010 will occur in Ontario (1,090), Quebec (800), British Columbia (360) and Alberta (255).