Ventana Announces FDA Approval Of Antibody To Assess Whether Breast Cancer Patients Should Be Treated With Herceptin

Ventana Medical Systems announced Wednesday it has received FDA approval for an antibody to aid in assessing whether breast cancer patients should be treated with Genentech's Herceptin, Reuters reports (Reuters, 1/18). FDA in 1998 approved Herceptin for treatment of advanced HER2-positive cancer that has spread beyond the breast. HER2-positive cancer is an aggressive form of the disease found in about 25% of breast cancer patients that involves extra copies of the HER2 protein. FDA in November 2006 expanded Herceptin's approval to include treatment of breast cancer when it has not spread beyond the breast or lymph nodes in patients who have undergone a lumpectomy or mastectomy (Kaiser Daily Women's Health Policy Report, 11/20/06). The Ventana antibody aims to detect presence of the HER2. FDA also approved the antibody to be used with the Ventana Image Analysis System (AP/BusinessWeek, 1/18). The system, which FDA approved in October 2006, is a breast cancer screening device used in combination with p53 -- a biomarker that suppresses tumors and is used in cancer diagnosis (Kaiser Daily Women's Health Policy Report, 10/13/06).

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