What is the connection between HER-2 status and Herceptin® therapy selection?
The Herceptin package insert states that detection of HER-2 status is necessary for selection of patients appropriate for Herceptin therapy. In a single-arm study of Herceptin as a single agent no relapsed metastatic breast cancer, the overall response rate in 173 patients with FISH positive tumors tested was 19%, whereas no objective responses were observed in patients with FISH( -) tumors. All patients’ specimens had previously demonstrated over expression of HER-2 at the 2+ or 3+ level by IHC. For more information on HER-2 testing and Herceptin, visit www.Herceptin.com.