Thursday, Aug 29, 2002
South San Francisco, Calif. -- August 29, 2002 --Genentech, Inc. (NYSE: DNA) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) to include information about a breast cancer gene-detection test method called FISH (fluorescence in situ hybridization) (PathVysion™) into the labeling of the product insert of Herceptin® (Trastuzumab). FISH is a diagnostic testing method used to detect HER2 (human epidermal growth factor receptor2) gene amplification in a patient's breast cancer cells.
In addition to including FISH as an appropriate diagnostic method for identifying women with metastatic breast cancer who could benefit from Herceptin therapy, the new information in the product insert shows that patients enrolled in Genentech’s pivotal trials whose tumors showed HER2 gene amplification benefited from treatment. In a retrospective analysis, patients selected using FISH testing treated with Herceptin in addition to standard chemotherapy had a 30 percent decrease in the risk of death and a 56 percent decrease in the risk of disease progression compared to patients treated with chemotherapy alone.
Herceptin is one of the first examples to demonstrate the benefits of a targeted medicine,” said Gwen Fyfe, M.D., Genentech's senior director of Oncology, Medical Affairs. “In our pivotal trial Herceptin in combination with chemotherapy demonstrated an increased survival benefit compared to chemotherapy alone, demonstrating the importance of identifying appropriate candidates for Herceptin therapy.”
Genentech submitted its sBLA to the FDA for the product insert change in March 2001. In December 2001, the Oncologic Drugs Advisory Committee (ODAC) to the FDA voted unanimously to recommend including the PathVysionTM FISH assay in the Herceptin package insert. The Herceptin package insert now includes both FISH and immunohistochemistry (IHC) as appropriate methods to identify HER2 positive patients.
FISH testing measures the number of genes in each cell, using fluorescent dye so the HER2 genes can be visualized and counted with a special microscope. More than the normal two HER2 genes per cell are present in HER2 positive breast cancer. Women whose cancer cells contain too many copies of the HER2 gene are candidates for Herceptin therapy. Herceptin is designed specifically to block the cancerous growth-promoting products of the excessive number of HER2 genes. The PathVysion FISH assay is marketed by Vysis, Inc., a wholly owned subsidiary of Abbott Laboratories (NYSE: ABT).
Herceptin is a targeted therapeutic antibody treatment for women with HER2
(human epidermal growth factor receptor2) positive metastatic breast cancer, an especially aggressive form of the disease that affects approximately one-fourth of women with breast cancer. Special testing is required to identify women who are HER2 positive and candidates for treatment with Herceptin.
Herceptin received FDA approval in September 1998 for use in women with metastatic breast cancer who have tumors that overexpress the HER2 protein. It is indicated for treatment of patients both as first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy. Herceptin is marketed in the United States by Genentech and internationally by F. Hoffmann-LaRoche.
In clinical trials, Herceptin has shown an important survival benefit when used in combination with chemotherapy. In December 2001, Genentech received FDA approval to include data that showed a 24 percent increase in 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).
Herceptin Safety Profile
Herceptin therapy does involve risks. Serious side effects have occurred in patients treated with Herceptin. Severe hypersensitivity reactions (including anaphylaxis), infusion reactions, and pulmonary events have been infrequently reported. Rarely, these were fatal. Serious reactions were treated by discontinuing Herceptin and administering supportive therapy. In clinical trials, the incidence and severity of cardiac dysfunction was highest in patients receiving Herceptin with anthracyclines. Most patients responded to medical therapy, including discontinuation of Herceptin. However, some patients were successfully managed while continuing Herceptin therapy. Patients receiving Herceptin should be monitored for deteriorating cardiac function.
In clinical trials, approximately 40 percent of patients experienced symptoms such as chills and fever during the first infusion. These and other symptoms, including nausea, vomiting, and pain, occurred infrequently with subsequent infusions. There was an increased incidence of anemia leukopenia, diarrhea, and infection when Herceptin was used in combination with chemotherapy.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes ten biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
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