Food and Drug Administration

Oncologic Drugs Advisory Committee

September 10, 2001

Briefing Information

Clinical Trial Designs for First-Line Hormonal Treatment of Metastatic Breast Cancer

Clinical Trial Designs for First-Line Hormonal Treatment of Metastatic Breast Cancer, FDA Presentation Susan Honig, M.D.   ppt   htm   pdf

NDA 21-236 IntraDose (Cisplatin/Epinephrine Injectable Gel)

Matrix Pharmaceutical Inc.

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.

Background Document   pdf   doc

Errata for Background Document   pdf   htm   doc

Appendix 1:  Treatment Goal Questionnaire and Patient Benefit   pdf   htm

Appendix 2:  Individual Outcomes of Therapy   pdf   htm

Appendix 3:  Primary Study Results Before and After Amendment V   pdf   htm

Appendix 4:  Treatment Outcomes: Stratum 3   pdf   htm

Appendix 5:  Supportive Clinical Studies   pdf   htm

Appendix 6:  Proposed Labeling   pdf   htm

Photos 414-2137    pdf   doc

Synopsis Patient 414-2137   pdf   doc

Synopsis Patient 414-5134   pdf   doc

Synopsis Patient 414-5301   pdf   doc

Photos 414-5348   pdf   doc

Synopsis Patient 414-5348   pdf   doc

Synopsis Patient 514-1998   pdf   doc

Photos 514-2660   pdf   doc

Synopsis Patient 514-2660   pdf   doc

FDA Background Information

Clinical Pharmacology/Biopharmaceutics Review   pdf   htm

FDA Briefing Document   pdf   htm

Summary of Statistical Review and Evaluation   pdf   htm