Food and Drug Administration
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee
70th Meeting
Advisors and Consultants Staff Conference Room
5630 Fishers Lane
Rockville, Maryland
Tentative Agenda
January 31, 2002
8:30 Call to Order and Opening Remarks Stacy Nerenstone, M.D.
Chair, ODAC
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Executive Secretary, ODAC
Open Public Hearing
Ann E. Fonfa – The Annie Appleseed Project (letter)
sNDA 21-386, Zometa ® (zoledronic acid for injection), Novartis Pharmaceuticals Corporation
- indicated for the treatment of bone metastases in patients with multiple myeloma, breast cancer,
prostate cancer and other solid tumors
9:00 Sponsor Presentation Novartis Pharmaceuticals Corporation
Introduction; Study 010
10:00 FDA Presentation
Study 010 Grant Williams, M.D.
Medical Team Leader
Division of Oncology Drug Products
10:20 Questions from the Committee
10:50 Break
11:05 Sponsor Presentation Novartis Pharmaceuticals Corporation
Introduction; Studies 039 and 011
11:50 FDA Presentation Amna Ibrahim, M.D.
Studies 039 and 011 Medical Officer
Division of Oncology Drug Products
Safety Review Nancy Scher, M.D.
Medical Officer
Division of Oncology Drug Products
12:30 Questions from the Committee
1:00 Lunch
1:45 Open Public Hearing
2:15 Committee Discussion and Vote
4:00 Adjourn