Food and Drug Administration

Oncologic Drugs Advisory Committee

December 5, 2001

Slides

Immunohistochemistry for Therapeutic Target Identification:  The Total Test System, Timothy J. O'Leary, Armed Forces Institute of Pathology   ppt   htm

FISH Technology and its Application to Gene Amplication Analysis, Michael S Watson, PhD   ppt   htm

Real world HER2 testing - ar they reliable?  Result of the planned anlysis of theinitial 104 cases enrolled by IHC in NSABP B-31, Soonmyung Paik, MD, National Surgical Adjuvant Breast and Bowel Project   ppt   htm

Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing Node-Positive Breast Cancenter, Edith A Perez   ppt   htm

Diagnostic Assays to Plan Specific Drug Treatment, Elizabeth Hammond MD   ppt   htm

Trastuzumab Labeling Supplement to Include FISH Testing as a Method to Select Patients for Treatment, FDA Clinical Review    ppt   htm

Herceptin (Trastuzamab), Marianne Armstrong, PhD, Genetech, Inc.   pdf