Food and Drug Administration

Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

64^th Meeting

Holiday Inn

Bethesda, Maryland

Agenda December 13-14, 1999

9:00 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

Barry Kupsch – Barrhead, A.B., Canada
Gaetana Grobluski – Nesconset, New York
Nancy W. Borcherding – Southgate, Kentucky
John H. Carter – Albany, New York
Judy Jones – Mycosis Fungoides Foundation
Carroll D. Cruse – Grayson, Louisiana (letter)
Margaret Russotto – Cranford, New Jersey (letter)
Tim McVoy – Clearwater, Florida (letter)

NDA 21-055, Targretin® (bexarotene) Capsules, 75 mg., Ligand Pharmaceuticals Inc.

- indicated for the treatment of cutaneous manifestations in patients with all clinical stages of CTCL (IA-IVB) in the following categories: patients with early stage CTCL who have not tolerated other therapies, patients with refractory or persistent early stage CTCL, and patients with refractory advanced stage CTCL

9:15 Sponsor Presentation Ligand Pharmaceuticals, Inc.

Introductions and Background Howard T. Holden, Ph.D.

Overview of CTCL Francine M. Foss, M.D.
New England Medical Center

Targretin Capsules Efficacy Results Richard C. Yocum, M.D.

Targretin Capsules Safety Findings Steven D. Reich, M.D.

A Clinical Investigator’s Perspective Kenneth B. Hymes, M.D.
New York University

Madeline Duvic, M.D.
M.D. Anderson Cancer Center

Summary and Questions Howard T. Holden, Ph.D.

10:15 Questions from the Committee

10:45 Break

11:00 FDA Presentation Oluwole Odujinrin, M.D.
FDA Reviewer

11:30 Questions from the Committee

12:00 Committee Discussion and Vote

ODAC Discussants Kim A. Margolin, M.D.
ODAC Member

Douglas Blayney, M.D.
ODAC Member

12:30 Lunch

December 13, 1999 – Afternoon Session

1:30 Open Public Hearing

Gaetano Giorno – Alliance for Lung Cancer Advocacy, Support and Education (ALCASE)
Scott Rivers - ALCASE
Randolph W. Urmston – Seattle, Washington (letter)
Charles Ammerman – Rockdale, Texas (letter)
David Tyre – Maysville, North Carolina (letter)

NDA 20-449/S-011 - Taxotere® (docetaxel) for Injection Concentrate,

Rhone-Poulenc Rorer Pharmaceuticals Inc.

indicated for the treatment of patients with locally advanced or metastatic Non-small Cell Lung Cancer after failure of prior chemotherapy

1:45 Sponsor Presentation Rhone-Poulenc Rorer Pharmaceuticals Inc.

Introduction Philip Chaikin, Pharm.D., M.D.

Overview of NSCLC treatment and Phase 2 Data Mark Green, M.D.

Hollings Cancer Center

Medical University of South Carolina

Pivotal Study TAX317 Frances Shepherd, M.D.

Princess Margaret Hospital

Toronto, Ontario

Pivotal Study TAX320 Frances Fossella, M.D.

University of Texas

M.D. Anderson Cancer Center

Quality of Life Richard Gralla, M.D.

Alton Ochner Cancer Institute

New Orleans, Louisiana

Benefit/Risk Mark Green, M.D.

Safety Profile/Conclusion Philip Chaikin, Pharm. D., M.D.

2:45 Questions from the Committee

3:15 Break

3:30 FDA Presentation Donna Griebel, M.D.
FDA Reviewer

4:00 Questions from the Committee

4:30 Committee Discussion and Vote

ODAC Discussants Richard Schilsky, M.D.
ODAC Member

Derek Raghavan, M.D., Ph.D.
ODAC Member

5:00 Adjourn

December 14, 1999

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

Introduction of Committee

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

Design and Analysis of Active Control Clinical Trials

Interpretation and Analysis of Active Control Robert Temple, M.D.
Equivalence or Non-inferiority Trials Director, Office of Drug Evaluation I

Bayesian Design and Analysis of Active Control Richard M. Simon, D.Sc
Clinical Trials ODAC Member

10:00 Break

10:15 Open Public Hearing

Abby Meyer – National Organization for Rare Disorders
Jean Marie Baxter – Deer Park, New York
Beth Schreiber – Boynton Beach, Florida
Pat Weidner – Youngstown, Ohio
Leon Wang, Ph.D. – Suffern, New York (letter)
Ronald Fuller – Dallas, Texas (letter)

NDA 21-156, Celebrex ™ (celecoxib), G. D. Searle & Co.

indicated for the reduction and regression of adenomatous colorectal polyps in Familial Adenomatous Polyposis patients

10:30 Sponsor Presentation G. D. Searle & Co.

Introduction Richard Spivey, Pharm.D., Ph.D.
Vice-President, Worldwide Regulatory Affairs

Background Philip Needleman, Ph.D.
Co-President
Chief Scientist, Monsanto

Gary Kelloff, M.D.
Chief of Chemopreventive Agent Development,
Research Group/NCI – Division of Cancer Prevention

Pre-Clinical Jaime L. Masferrer, Ph.D.
COX-2 Cancer Project Leader
Group Leader Discovery Pharmacology

Clinical: Familial Adenomatous Polyposis Bernard Levin, M.D.
Vice President for Cancer Prevention
M.D. Anderson Cancer Center

FAP Study: Rationale, Design/Logistics, Ernest T. Hawk, M.D., M.P.H.
Efficacy Data Chief, Gastrointestinal & other Cancer Research Group
Division of Cancer Prevention, NCI

FAP Study: Safety Data Gary B. Gordon, M.D., Ph.D.
FAP Follow-up Trial Director, Cancer Prevention/Treatment Clinical Research

Conclusion/Moderator Richard N. Spivey, Pharm. D., Ph.D.

Philip Needleman, Ph.D.

11:30 Questions from the Committee

12:00 Lunch

1:00 FDA Presentation Judy Chiao, MD
FDA Reviewer

1:30 Questions from the Committee

2:00 Open Public Hearing

Carolyn Aldige – Cancer Research Foundation of America

2:15 Committee Discussion and Vote

ODAC Discussants Christina Surawicz, M.D.
Member, Gastrointestinal Drugs Advisory Committee

David Kelsen, M.D.
ODAC Member

3:15 Adjourn