Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

72nd Meeting

Holiday Inn

8777 Georgia Avenue

Silver Spring, Maryland


DRAFT 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

Open Public Hearing


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

- indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who
have previously received platinum-based chemotherapy


9:45 Sponsor Presentation AstraZeneca Pharmaceuticals LP

10:45 Break

11:00 FDA Presentation

11:45 Questions from the Committee

12:45 Lunch

1:45 Committee Discussion and Vote

4:00 Adjourn