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

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 Burkhard Daldrup, Ph.D.

Pathophysiology of Metastatic Bone Disease

and the Role of Bisphosphonates Robert Coleman, M.D., FRCP

ZOMETA® in Breast Cancer and Multiple Myeloma James Berenson, M.D.

10:00 FDA Presentation

ZOMETA® in Breast Cancer and Multiple Myeloma Grant Williams, M.D.

(Study 010) Medical Team Leader

Division of Oncology Drug Products

10:20 Questions from the Committee

10:50 Break

11:05 Sponsor Presentation Novartis Pharmaceuticals Corporation

ZOMETA® in Prostate Cancer and Matthew Smith, M.D.

Solid Tumors Other Than Prostate Cancer Robert Coleman, M.D., FRCP

and Breast Cancer

Conclusions David Parkinson, M.D.

11:50 FDA Presentation

ZOMETA® in Prostate Cancer and Amna Ibrahim, M.D.

Solid Tumors Other Than Prostate Cancer Medical Officer

and Breast Cancer (Studies 039 and 011) Division of Oncology Drug Products

Safety Review (Studies 010, 011 and 039) 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 Introduction to the Issues Grant Williams, M.D.

Committee Discussion and Vote

4:00 Adjourn