Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

71^th Meeting
Holiday Inn
8120 Wisconsin Avenue
Bethesda, Maryland

Tentative Agenda February 27, 2002

8:00 Call to Order and Opening Remarks Stacy Nerenstone, M.D.
Chair, ODAC

Introduction of Committee

Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Executive Secretary, ODAC

Open Public Hearing

Trial Design Considerations and Appropriate Patient Populations
for Studies of Investigational Agents for Adjuvant Therapy of Melanoma
Given the Availability of an Approved agent for this Indication

9:00 Efficacy and Safety of Adjuvant High-dose Interferon for High-risk Melanoma: ECOG and Intergroup Trial
John M. Kirkwood, MD - University of Pittsburgh Cancer Institute

Cure Rate Models and Adjuvant Trial Design for ECOG Studies in the Past, Present and Future
Joseph G. Ibrahim, PhD - Harvard School of Public Health

9:45 FDA presentation

10:15 Break

10:30 Committee Discussion

12:00 Lunch

1:00 Open Public Hearing

Appropriate Study Design and Control for the Proposed Phase 3 Trial of
Investigational New Drug (IND) 2885, Melacine® (melanoma vaccine), Corixa Corporation, for adjuvant treatment of melanoma

1:15 Sponsor Presentation Corixa Corporation

Melacine® vaccine as adjuvant therapy for Stage II melanoma: Martin A. Cheever, M.D.
Issues for further development and regulatory approval Vice President, Medical Affairs

2:15 Committee Discussion

5:00 Adjourn