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

lude, in the product label, data that showed an improved median overall survival for women with HER2-positive metastatic breast cancer treated initially with Herceptin and chemotherapy, compared to chemotherapy alone (median 25.1 months compared to 20.3 months).

In November 2006, Herceptin was FDA-approved as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel for the adjuvant treatment of HER2-positive, node-positive breast cancer based on results that showed Herceptin reduced the risk of cancer recurrence by 52 percent. Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment -- surgery with or without radiation therapy -- with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease.

There are now four studies in the adjuvant setting demonstrating that the addition of Herceptin to a chemotherapy regimen increased disease-free survival for women with early-stage HER2-positive breast cancer. Nearly 400,000 women have been treated with Herceptin worldwide since its first approval in 1998.

Herceptin Safety Profile

Herceptin administration can result in left ventricular dysfunction and congestive heart failure (CHF). The incidence and severity of left ventricular cardiac dysfunction/CHF were highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens. Physicians should discontinue Herceptin treatment in patients receiving adjuvant therapy for breast cancer and strongly consider discontinuation of Herceptin in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function.

Patients receiving Herceptin should undergo frequent monitoring for deteriorating left ventricular function. More frequent monitoring should be employed in patients with preexisting cardiac dysfunction receiving Herceptin. Monitoring will not ident
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