Holiday Inn

Silver Spring, Maryland

Tentative Agenda September 16-17, 1999

8:00 Call to Order and Opening Remarks Richard Schilsky, M.D.
Chair, ODAC

Introduction of Committee

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

Open Public Hearing

Michael Cohen – Institute for Safe Medication Practices

Laurence F. Daspit – Spring, Texas

NDA 21-053, UFT^® (tegafur and uracil) Capsules, Bristol-Myers Squibb Company

• indicated with leucovorin calcium tablets for the first-line treatment of metastatic colorectal cancer

8:15 Sponsor Presentation Bristol-Myers Squibb Company

Introduction Renzo Canetta, M.D.
Vice President, Clinical Oncology

Chemotherapy for Metastatic Colorectal Cancer John MacDonald, M.D.
St. Vincent’s Comprehensive Cancer Center

UFT Development Robert Diasio, M.D.
University of Alabama

Pivotal Study – 011 Steven Benner, M.D. M.H.S.
Group Director, Clinical Oncology

Confirmatory Study James Carmichael, M.D., Ph.D.
Nottingham City Hospital, England

Concluding Remarks Renzo Canetta, M.D.

9:15 Questions from the Committee

9:45 Break

10:00 FDA Presentation Robert M. White, M.D.
FDA Reviewer

11:00 Questions from the Committee

11:30 Committee Discussion and Vote

ODAC Discussants David Kelsen, M.D.
ODAC Member

Kim Margolin, M.D.
ODAC Member

James Krook, M.D.
ODAC Consultant

12:00 Lunch

1:00 Open Public Hearing

Michael Cohen – Institute for Safe Medication Practices

Judy Perotti (or TBA) – Y-ME National Breast Cancer Organization

Laura Meeker – Arlington, Virginia

1:15 Sponsor Presentation The Liposome Company, Inc.

2:15 Questions from the Committee

2:45 Break

3:00 FDA Presentation Patricia Cortazar, M.D.
FDA Reviewer

4:00 Questions from the Committee

4:30 Committee Discussion and Vote

ODAC Discussants William Gradishar, M.D.
ODAC Member

Stacy Nerenstone, M.D.
ODAC Member

5:00 Adjourn

8:00 Call to Order and Opening Remarks Kim Margolin, M.D.
Acting Chair, ODAC

Introduction of Committee

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

Open Public Hearing

Judy Perotti (or TBA)– Y-ME National Breast Cancer Organization

• indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard combination therapy

8:15 Sponsor Presentation Bristol-Myers Squibb Company

Introduction David Tuck, M.D.

Director, Clinical Oncology

Breast Cancer Chemotherapy Larry Norton, M.D.
Memorial Sloan Kettering Cancer Center

Inter-Group 0148 Results Craig Henderson, M.D.
University of California, San Francisco

Concluding Remarks Renzo Canetta, M.D.
Vice President, Clinical Oncology

9:15 Questions from the Committee

9:45 Break

10:00 FDA Presentation James O’Leary, M.D.
FDA Reviewer

11:00 Questions from the Committee

11:30 Committee Discussion and Vote

ODAC Discussants William Gradishar, M.D.
ODAC Consultant

Joyce O’Shaughnessy, M.D.
ODAC Consultant

12:00 Lunch

1:00 Call to Order and Opening Remarks Richard Schilsky, M.D.
Chair, ODAC

Introduction of Committee

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

Open Public Hearing

1:15 Update on the Preliminary Results of EST 1690

(ECOG Intergroup Study of INTRON A for the adjuvant treatment of melanoma)

John Kirkwood, M.D.
University of Pittsburgh

- indicated for use as adjuvant treatment of surgically resected malignant melanoma without clinical evidence of nodal disease, AJCC stage II (Breslow thickness>1.5 mm, N0)

1:30 Sponsor Presentation Hoffman-La Roche Inc.

Clinical Overview of Malignant Melanoma Antonia Buzaid, M.D.
University of Sao Paulo, Brazil

Data on Roferon®-A in the Treatment of Leon Hooftman, M.D.
Stage II Malignant Melanoma Director of Oncology

2:30 Questions from the Committee

3:00 Break

3:15 FDA Presentation Massimo Cardinali, M.D.
FDA Reviewer

Peter A. Lachenbruch, Ph.D.
FDA Reviewer

4:00 Questions from the Committee

4:30 Committee Discussion and Vote

ODAC Discussants Janice Dutcher, M.D.
ODAC Consultant

(TBA)

5:00 Adjourn