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