Food and Drug Administration

Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

70^th 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