Food and Drug Administration

Oncologic Drugs Advisory Committee

December 5, 2001

Briefing Information

Afternoon Session

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.

Sponsor Information


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]