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