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

Disclaimer

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]