Food and Drug Administration

Oncologic Drugs Advisory Committee

January 31, 2002

Slides

ZometaŽ (zoledronic acid for injection)

Sponsor Slides - Novartis Pharmaceuticals Corporation

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.

Introduction, Burkhard Daldrup PhD, Global Head, Regulatory Affairs, Novartis Pharmaceuticals Corporation   ppt   htm

Pathophysiology of Metastatic Bone Disease and the Role of Bisphosphonates, Prof. Robert Coleman, MD, FRCP, Cancer Research Centre, Weston Park Hospital   ppt   htm

ZometaŽ in Breast Cancer and Multiple Myeloma: Pamidronate-Controlled Trial (010), James Berenson, MD, Cedars-Sinai Medical Center   ppt   htm

FDA Presentation

ZometaŽ for Patients with Bone Metastases, Overview and Review of Study 010, Grant Williams, MD, FDA   ppt   htm

Sponsor Slides - Novartis Pharmaceuticals Corporation

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.

ZometaŽ in Prostate Cancer and Solid Tumors Other Than Prostate Cancer and Breast Cancer: Placebo-Controlled Trials, Matthew Smith, MD, PhD, Massachusetts General Hospital, Harvard Medical School, Prof. Robert Coleman, MD, FRCP, Cancer Research Centre, Weston Park Hospital   ppt   htm

ZometaŽ, Conclusions, David R. Parkinson, Global Head, Clinical Research and Development, Novartis Pharmaceuticals Corporation   ppt  htm

Support Slides  ppt   htm

Food and Drug Administration

Zometa for Prostate Cancer Bone Metastases, Protocol 039, Amna Ibrahim, MD   ppt   htm

sNDA 21-386, Zometa Safety Review, Nancy S Scher, MD, FDA   ppt   htm