Food and Drug Administration
Oncologic Drugs Advisory Committee
December 5, 2001
BLA 103792\5008, a labeling supplement for Herceptin® (trastuzumab), Genentech, Inc.
- indicated for the treatment of patients with metastatic breast cancer who have tumors which overexpress HER-2, to include the use of fluorescence in situ hybridization (FISH) testing using the PathVysion™ HER-2 DNA Probe Kit, Vysis, Inc., as a diagnostic method to select patients for Herceptin® therapy.
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Genentech Inc Information [pdf version]
Food and Drug Information
Clinical Review Briefing Document [pdf version] [htm version] [Word version]
Clinical Review Briefing Document: Appendix B - Path Vysion Current Package Insert [pdf version]
Clinical Review Briefing Document: Appendix C - HercepTest Current Package Insert [pdf version]
Clinical Review Briefing Document: Appendix D - Trastuzumab Package Insert [pdf version]