Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

72nd Meeting

Holiday Inn

8777 Georgia Avenue

Silver Spring, Maryland

Agenda September 24, 2002


8:30 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

8:45 Open Public Hearing

NDA 21-399, IRESSA® (gefitinib), AstraZeneca Pharmaceuticals LP

cancer who have previously received platinum-based chemotherapy


9:45 Sponsor Presentation AstraZeneca Pharmaceuticals LP

IRESSAâ (ZD1839) Monotherapy for NSCLC

Introduction and Rationale for George Blackledge, M.D., Ph.D., MB, F.R.C.P.
Clinical Development Clinical Vice President of Oncology

Recurrent Non-Small Cell Lung Cancer Frances A. Shepherd, M.D., F.R.C.P.C.
Director, Division Medical Oncology
University of Toronto

IRESSAâ (ZD1839) Efficacy Ronald B. Natale, M.D.
Medical Director
Cedars Sinai Comprehensive Cancer Center

IRESSAâ Safety Profile Alan B. Sandler, M.D., F.A.C.P.
Associate Professor of Medicine
Vanderbilt University

10:45 Break

11:00 FDA Presentation

Introduction and Regulatory Background Grant Williams, M.D.
Deputy Director
Division of Oncology Drug Products, FDA

Review of the Clinical Trials Martin Cohen, M.D.
Medical Reviewer, FDA

Statistical Analysis Rajeshwari Sridhara, Ph.D.
Statistical Reviewer, FDA

Summary Grant Williams, M.D.

11:45 Questions from the Committee

12:45 Lunch

1:45 Committee Discussion and Vote

4:00 Estimated Time of Adjournment