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Genentech Herceptin label change

Executive Summary

Genentech's Herceptin (trastuzumab) supplemental BLA will be reviewed by FDA's Oncologic Drugs Advisory Committee on the afternoon of Dec. 5. Proposed labeling supplement includes use of fluorescence in situ hybridization testing using PathVysion HER-2 DNA probe kit from Vysis as diagnostic method to select patients for therapy with the breast cancer agent. In the morning, committee will discuss development of diagnostic immunohistochemistry and fluorescence in situ hybridization assays, with focus on characterization and interpretation of assay results. Meeting will begin at 8 a.m. at the Holiday Inn in Silver Spring, Md
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PS038737

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