Food and Drug Administration
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee
68th Meeting
Holiday Inn - Bethesda, Maryland
Proposed Agenda
September 10-11, 2001
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
Clinical Trial Designs for First-Line Hormonal Treatment of Metastatic Breast Cancer
8:30 FDA presentation Susan Honig, M.D.
FDA Medical Reviewer
Patricia Cortazar, M.D.
FDA Medical Reviewer
Rajeshwari Sridhara, Ph.D.
FDA Statistical Reviewer
9:30 Questions from the Committee
10:00 Break
10:15 Committee Discussion
12:30 Lunch
September 10, 2001 – Afternoon Session
1:30 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
NDA 21-236, IntraDose® (cisplatin/epinephrine) Injectable Gel, Matrix Pharmaceutical, Inc.
- indicated for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck in patients who are not considered curable with surgery or radiotherapy
2:00 Sponsor Presentation Matrix Pharmaceuticals, Inc.
Introduction Stephen B. Howell, M.D.
University of California, San Diego
Current Management of Head and Neck Cancer Glenn Mills, M.D.
Louisiana State University
Pharmacologic rationale and challenges Stephen B. Howell, M.D.
associated with demonstration of clinical benefit
Clinical Study Results, Efficacy and Safety Richard D. Leavitt, M.D.
Senior Vice President, Medical Affairs
John Mackowiak, Ph.D.
Center for Outcomes Research
Risk/Benefit and Conclusions Glenn Mills, M.D.
3:00 Questions from the Committee
3:30 Break
3:45 FDA Presentation Grant Williams, M.D.
Medical Team Leader, FDA
Gregory Frykman, M.D.
FDA Medical Reviewer
Rajeshwari Sridhara, Ph.D.
FDA Statistical Reviewer
4:30 Questions from the Committee
5:00 Committee Discussion and Vote
5:30 Adjourn
September 11, 2001
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
BLA 125019, Zevalin™ (ibritumomab tiuxetan), IDEC Pharmaceuticals Corporation
- indicated for the treatment of patients with relapsed or refractory low grade, follicular or CD20+ transformed B cell Non-Hodgkins lymphoma (NHL) and rituximab refractory follicular NHL
8:30 Introduction Marjorie Shapiro, Ph.D.
FDA Product Reviewer
8:45 Sponsor Presentation IDEC Pharmaceuticals Corporation
Ibritumomab Tiuxetan (Zevalin™) Radioimmunotherapy of Non-Hodgkin’s Lymphoma
Opening Remarks Leslie L. Shelly, Ph.D.
Associate Director, Regulatory Affairs
Scientific and Medical Summary of Zevalin™ Christine A. White, M.D.
Vice President, Medical Affairs
9:30 Questions from the Committee
10:00 Break
10:15 FDA Presentation Philippe Bishop, M.D.
FDA Medical Reviewer
11:00 Questions from the Committee
11:30 Committee Discussion and Vote
12:15 Lunch
September 11, 2001 – Afternoon Session
1:00 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
NDA 20-637/S016, Gliadel® Wafer (carmustine), Guilford Pharmaceuticals Inc.
- indicated for use as a treatment to significantly prolong survival and maintain overall function (as measured by preservation of Karnovsky Perfomance Status) and neurological function in patients with malignant glioma undergoing primary and/or recurrent surgical resection
1:30 Sponsor Presentation Guilford Pharmaceuticals Inc.
Introductions Louise Peltier
Senior Director, Regulatory Affairs
Overview of Primary Malignant Glioma: Alan Hamilton, M.D.
Clinical Features and Treatment University of Arizona School of Medicine
Phase III Trials (T-301 and C-0190) Dana Hilt, M.D.
Vice President of Clinical Research
Statistical Analytic Methods Stephen Piantadosi, M.D., Ph.D.
Johns Hopkins School of Medicine
Phase III Trial (T-301) Efficacy and Safety Results Dana Hilt, M.D.
2:30 Questions from the Committee
3:00 Break
3:15 FDA Presentation Alison Martin, M.D.
Medical Team Leader, FDA
Alla Shapiro, M.D.
FDA Medical Reviewer
Ning Li, Ph.D.
FDA Statistical Reviewer
4:30 Questions from the Committee
5:00 Committee Discussion and Vote
5:30 Adjourn