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Updated Overall Survival Data From Pivotal Herceptin Adjuvant,Studies in HER2-Positive Breast Cancer

monitis, which occurred at a rate of less than 1 percent.

An update of cardiac function in patients enrolled in the NSABP B-31 trial presented by Priya Rastogi, M.D., of the University of Pittsburgh Cancer Institute (Abstract #513 -- Monday, June 4, 2007, 9:15 a.m. CDT), showed that the five-year cumulative incidence of cardiac events in the Herceptin-containing treatment arm was 3.8 percent, compared to 0.9 percent in the control arm. The cumulative incidence of cardiac dysfunction in the Herceptin arm remained stable, with no increase in cardiac events between year three and year five of follow-up, providing important insights into the long-term cardiac effects of Herceptin.

About Herceptin

Herceptin is a targeted therapeutic antibody treatment for women who have tumors that overexpress the human epidermal growth factor receptor 2 (HER2) protein. HER2-positive breast cancer is an especially aggressive form of the disease that affects approximately one-fourth of women with breast cancer. Research has shown that women with HER2-positive breast cancer have a greater likelihood of recurrence, poorer prognosis, and decreased survival compared to women with HER2-negative breast cancer. Special testing is required to identify women who have HER2-positive breast cancer and who may be candidates for treatment with Herceptin.

Herceptin is the only targeted biologic therapy approved for treatment of HER2-positive breast cancer in the adjuvant and metastatic settings. Herceptin first received FDA approval in September 1998 for use in metastatic breast cancer, as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy. In clinical trials of patients with HER2-positive metastatic breast cancer, Herceptin, in combination with chemotherapy (paclitaxel), was the first anti-HER2 agent to demonstrate an improvement in survival in a Phase III study. In December 2001, Genentech received FDA approval to inc
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