Food and Drug Administration
Oncologic Drugs Advisory Committee
January 31, 2002
Slides
Zometa® (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
Zometa® in Breast Cancer and Multiple Myeloma: Pamidronate-Controlled Trial (010), James Berenson, MD, Cedars-Sinai Medical Center ppt htm
FDA Presentation
Zometa® 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.
Zometa® 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
Zometa®, Conclusions, David R. Parkinson, Global Head, Clinical Research and Development, Novartis Pharmaceuticals Corporation 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