FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING

DRAFT AGENDA

December 16, 2003

Advisors and Consultants Conference Room, Rockville, Maryland

8:00 a.m. Call to Order Donna Przepiorka, M.D., Chair, ODAC

Introduction of Committee

Conflict of Interest Statement Johanna Clifford, M.S., RN, BSN

Executive Secretary, ODAC

8:10 a.m. Opening Remarks

8:15 a.m. General Regulatory Background

8:25 a.m. Endpoints for Past Approvals

8:35 a.m. Time to Progression Endpoint

8:55 a.m. Challenges in Oncology Clinical Trials

9:25 a.m. Clarification Questions to Presenters

9:35 a.m. Break

9:50 a.m. Open Public Hearing

10:20 a.m. Questions for Discussion

12:00 p.m. Lunch

1:00 p.m. NSCLC Regulatory Background

1:20 p.m. FDA/ASCO NSCLC Workshop Summary .

1:50 p.m. Patient Reported Outcomes in NSCLC

2:05 p.m. Clarification Questions to Presenters

2:15 p.m. Break

2:30 p.m. Open Public Hearing

3:00 p.m. Questions for Discussion

5:00 p.m. Adjourn