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 Introduction to Tositumomab Therapeutic Regimen Terrye G. Zaremba, Ph.D.

BLA Committee Chairperson

CBER, FDA

1:30 Sponsor Presentation Corixa Corporation

Disease Outcome and Therapy for Low-Grade Richard Fisher, M.D.

and Transformed NHL University of Rochester

Efficacy and Safety Overview: Basis for Approval Cindy Jacobs, Ph.D., M.D.

Senior Vice-President, Clinical Research

Risk/Benefit Assessment James Armitage, M.D.

University of Nebraska

2:30 Break

2:45 FDA Presentation Center for Biologics Evaluation and Research

Stephen Litwin, M.D.

Medical Reviewer, FDA

3:45 Questions from the Committee

4:15 Open Public Hearing

4:30 Committee Discussion and Vote

ODAC Discussants James Bridges, M.D.

CBER Consultant

James Krook, M.D.

CDER Consultant

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

Introduction and Regulatory History Gerard T. Kennealey, M.D.

Need for CASODEXâ in Early Prostate Cancer Howard I. Scher, M.D.

Memorial Sloan-Kettering Cancer Center

EPC Trial Program: Efficacy and Safety William A. See, M.D.

Medical College of Wisconsin

Relevance to Clinical Practice Mark S. Soloway, M.D.

University of Miami School of Medicine

Summary and Conclusions Gerard T. Kennealey, M.D.

9:45 Break

10:00 FDA Presentation

Background and Review Issues Daniel Shames, M.D.

Director, Division of Reproductive and

Urologic Drug Products, FDA

Medical Review Findings Scott Monroe, M.D.

Medical Reviewer, FDA

Summary and Introduction of Questions Daniel Shames, M.D.

11:00 Questions from the Committee

11:45 Open Public Hearing

12:00 Lunch

1:00 Committee Discussion and Vote

3:00 Estimated Time of Adjournment