Herceptin- Breast Cancer Cure?

Is Herceptin™ the breast cancer cure we've been waiting for?

As women, breast cancer is often one of our greatest health fears. The search for a cure for this devastating disease has led to the development of a new drug that promises to extend and save the lives of thousands of women diagnosed with breast cancer. All that's needed now is FDA approval.

Genentech, Inc. a leading biotechnology company, filed a new drug application in May of 1998 with the FDA, for regulatory approval to market Herceptin™ (trastuzumab ) Anti-HER2 Humanized Monoclonal Antibody, as a treatment for breast cancer. Trastuzumab, was developed to block a protein receptor called HER2 which is present in excess amounts in approximately 30% of women with breast cancer.

A May 4, 1998, news release from Genetech said, "If Herceptin is approved for marketing, it will be a new biologic approach for the treatment of women with HER2-overexpressing metastatic breast cancer. HER2-overexpression affects 25-30% of breast cancer patients and is associated with more rapid cancer progression and shortened survival. Herceptin, the first monoclonal antibody for treatment of breast cancer, has been shown in laboratory studies to slow the growth of human breast cancer cells that over express HER2. Genentech's license application to the FDA is based on the results of two recent Phase III clinical trials. The results of these trials will be presented on May 17 at the annual meeting of the American Society of Clinical Oncology (ASCO). The preliminary results of these studies were announced by Genentech in December 1997."

According to the press release, "Approximately 1.6 million women have been diagnosed with breast cancer in the United States with 180,000 new cases diagnosed in any given year. Genentech estimates that there are approximately 164,000 women with metastatic breast cancer. Of these women, 25-30 percent have tumors that over express HER2 and would be candidates for this potential therapy."

Is Herceptin the drug we've been waiting for in the search for a cure for breast cancer? Trastuzumab alone may not be a complete cure for all women, but it may extend and save the lives of many of the 30% of women, who over- produce HER2; it is the first treatment developed from a scientific understanding of specific genetic changes which cause breast cancer. It is hoped that the technology which led to the development of trastuzumab will one day led scientists to develop other gene- specific, anti- cancer drugs.

Herceptin is not yet available to the public, but with the expected FDA approval, it should be available to breast cancer patients this fall.

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