Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

69th Meeting

Holiday Inn – Silver Spring, Maryland

Proposed Agenda December 5-6, 2001

8:30 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

Development of Diagnostic Assays Intended to Identify Patients

Who Might Benefit from Treatment with a Particular Therapeutic Product:

Characterization and Interpretation of Assay Results

9:00 Introduction

Immunohistochemistry Presentation

Fluorescence in situ Hybridization Presentation

10:45 Break

11:00 Data Presentations

11:20 Panel Discussion

12:00 Committee Discussion and Vote

12:45 Lunch

December 5, 2001 – Afternoon Session

1:45 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 103792\5008, a labeling supplement for Herceptin® (trastuzumab), Genentech, Inc.

- indicated for the treatment of patients with metastatic breast cancer who have tumors which overexpress HER-2, to include the use of fluorescence in situ hybridization (FISH) testing using the PathVysion™ HER-2 DNA Probe Kit, Vysis, Inc., as a diagnostic method to select patients for Herceptin® therapy.

2:15 Sponsor Presentation Genentech, Inc.

3:15 Questions from the Committee

3:45 Break

4:00 FDA Presentation

4:30 Questions from the Committee

5:00 Committee Discussion and Vote

5:30 Adjourn

 

December 6, 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

Camptosar® Injection (irinotecan hydrochloride injection), Pharmacia & Upjohn Company, combined with 5FU/leucovorin ("Saltz" regimen), approved for the first-line treatment of patients with metastatic colorectal cancer: Post-marketing safety issues

8:30 Sponsor Presentation Pharmacia & Upjohn Company

9:45 Questions from the Committee

10:15 Break

10:30 FDA Presentation

11:15 Questions from the Committee

11:45 Committee Discussion and Vote

12:30 Lunch

December 6, 2001 – Afternoon Session

1:15 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.

2:30 Questions from the Committee

3:00 Break

3:15 FDA Presentation

4:30 Questions from the Committee

5:00 Committee Discussion and Vote

5:30 Adjourn