Tuesday, Mar 31, 1998
South San Francisco, Calif. -- March 31, 1998 --Genentech, Inc. (NYSE: GNE) today announced that the U.S. Food and Drug Administration (FDA) has designated Herceptin (Trastuzumab), Genentech's humanized monoclonal antibody to the HER2 growth factor receptor, a Fast Track Product for the treatment of metastatic breast cancer.
Under the FDA Modernization Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition.
Genentech is working closely with the FDA to begin submitting portions of its Biologics License Application (BLA) for Herceptin with completion of filing on target for second quarter of this year. The actual six-month time period for priority review under the Prescription Drug User Fee Act (PDUFA) of 1992 does not officially begin until the application submission is complete.
Herceptin is a potential new biologic approach for the treatment of HER2 overexpressing metastatic breast cancer, an aggressive form of the disease that affects 25-30 percent of patients.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Eleven of the currently marketed biotechnology products stem from Genentech science. Genentech markets or promotes eight biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.
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