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