Food and Drug Administration
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee
8777 Georgia Avenue
Silver Spring, Maryland
AgendaSeptember 24, 2002
8:30 Call to Order and Opening Remarks Donna Przepiorka, M.D., Ph.D.
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.
Cedars Sinai Comprehensive Cancer Center
IRESSAâ Safety Profile Alan B. Sandler, M.D., F.A.C.P.
Associate Professor of Medicine
11:00 FDA Presentation
Introduction and Regulatory Background Grant Williams, M.D.
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
1:45 Committee Discussion and Vote
4:00 Estimated Time of Adjournment