Roche Announces Canadian Regulatory Approval of

Revolutionary Treatment Shown to Increase Survival in Advanced Breast Cancer Patients. The Canadian regulatory authorities granted marketing approval for Herceptin, Roche's novel treatment for metastatic, or advanced breast cancer. Herceptin is indicated for the treatment of metastatic breast cancer patients whose tumours substantially overexpress the HER2 protein. Herceptin is the first oncoreceptor-targeted treatment which has been shown in clinical trials to increase overall survival of patients. Herceptin will be available to Canadian patients as of today. Herceptin Prolongs Life "Herceptin represents the most significant survival benefit in advanced breast cancer in over 40 years. This treatment, when combined with chemotherapy, is the first to offer a survival benefit of 24 percent for women whose cancer overexpresses a protein called HER2 (human epidermal growth factor receptor 2). This type of cancer is very aggressive, extremely difficult to treat and associated with a poor prognosis. However, some Herceptin patients have now survived for five or six years, " said Herceptin study investigator, Dr. Brian Leyland-Jones, Minda de Gunzburg Professor and Chairman, Department of Oncology, McGill University in Montreal. Herceptin's Unique Mechanism of Action Also Results in Improved Side Effect Profile Herceptin works by targeting HER2-overexpressing tumours and blocking the HER2 receptors. This novel mechanism -- targeting a root cause of metastatic breast cancer -- translates into significant clinical benefits. Herceptin, when administered alone, was also found to be effective and well-tolerated by patients, who experienced almost none of the commonly observed side-effects associated with chemotherapy such as hair loss, nausea, vomiting and killing of immune system cells. Roche Continues Marketing Partnership with Genentech Genentech, the world's leading biotechnology company in which Roche owns a majority share, has already been marketing Herceptin in the United States since the fall of 1998. Roche has marketing rights for all countries outside the U.S. On 4 February 1999, Roche filed for marketing authorisation in the European Union. Roche is working very closely with regulatory authorities worldwide to make this important therapy available to patients as soon as possible. Roche and Genentech continue to work on a joint global development programme to explore the clinical efficacy and safety of Herceptin in other solid tumours that overexpress HER2, such as non-small cell lung and colorectal cancers. Herceptin complements the existing Roche portfolio of highly innovative oncology treatments, such as Xeloda(R) for the treatment of metastatic breast cancer, MabThera(R) for the treatment of follicular non-Hodgkin's lymphoma and Roferon-A(R), the first interferon treatment for different forms of cancer. Headquartered in Basel, Switzerland, Roche is one of the world's leading healthcare groups in the fields of pharmaceuticals, diagnostics, vitamins and fragrances and flavours. Roche's products and services address all stages of individual health maintenance and disease management, including prevention, diagnosis and treatment, thus enhancing people's well being and quality of life. ots Original Text Service: Roche Pharmaceuticals Internet: http://www.newsaktuell.de Contact: Kim Callahan, +1-212-453-2425, or Melinda Winter, +1-212-453- 2456, both of Fleishman-Hillard, for Roche Pharmaceuticals

Keywords PROTEXT-Roche Pharmaceuticals

Region
USA, Canada, U.N.

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Health service

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