Food and Drug Administration

Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

73^rd Meeting

Holiday Inn

8170 Wisconsin Avenue

Bethesda, Maryland

Agenda December 17-18, 2002

12:30 Call to Order and Opening Remarks Donna Przepiorka, M.D., Ph.D., Chair, ODAC

Introduction of Committee

Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D., Executive Secretary, ODAC

12:45 Open Public Hearing

BL STN 125011/0, Bexxar®, Tositumomab (Anti-B1) and Iodine¹³¹-Tositumomab

Corixa Corporation

- indicated for the treatment of patients with relapsed or refractory low-grade, follicular or transformed low-grade, B-cell non-Hodgkin's lymphoma (NHL) including patients with rituximab refractory follicular non-Hodgkin's lymphoma

1:15 Sponsor Presentation Corixa Corporation

2:15 Break

2:30 FDA Presentation

3:30 Questions from the Committee

4:30 Committee Discussion and Vote

5:30 Estimated Time of Adjournment

December 18, 2002

8:00 Call to Order and Opening Remarks Donna Przepiorka, M.D., Ph.D., Chair, ODAC

Introduction of Committee

Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D., Executive Secretary, ODAC

8:15 Open Public Hearing

NDA 20-498, S012, CASODEXÒ (150 mg bicalutamide), AstraZeneca Pharmaceuticals LP

indicated as (1) adjuvant therapy to radical prostatectomy and radiotherapy of curative intent in patients with locally advanced non-metastatic prostate cancer who have a high risk for disease recurrence or (2) immediate treatment of localized non-metastatic prostate cancer in patients for whom therapy of curative intent is not indicated

8:45 Sponsor Presentation AstraZeneca Pharmaceuticals LP

9:45 Break

10:00 FDA Presentation

11:00 Questions from the Committee

12:00 Lunch

1:00 Committee Discussion and Vote

3:00 Estimated Time of Adjournment