Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

Meeting Agenda

March 12-13, 2003

Versailles Ballroom

74^th Meeting Holiday Inn

Bethesda, MD

March 12, 2003

8:00 Call to Order and Opening Remarks Donna Przepiorka, M.D., Ph.D.

Chair, ODAC

Introduction of Committee

Conflict of Interest (COI) Statement Johanna Clifford, M.S.,RN, BSN

8:15 Open Public Hearing

8:45 Introduction – Accelerated Approval Process Richard Pazdur, M.D., Director

Ramzi Dagher, M.D., Medical Officer

Division of Oncology Drug Products

Center for Drug Evaluation & Research Division of Oncologic Drugs

9:15 Sponsor Presentation Steven Hamburger, Ph.D.

Johnson & Johnson Pharmaceutical

Research & Development, LLC

NDA 50-718 Doxil (doxorubicin hydrochloride liposome)

Indication: Treatment of Kaposi’s sarcoma in AIDS patients with disease that

has progressed on prior combination therapy or in patients who are intolerant

to such therapy.

9:30 FDA Comments & ODAC Discussion Bruce Redman, D.O.

ODAC Discussant

10:15 Break

COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

10:30 Sponsor Presentation Steven Hamburger, Ph.D.

Johnson & Johnson Pharmaceutical

Research & Development, LLC

NDA 50-718/S-006 Doxil (doxorubicin hydrochloride liposome)

Indication: Treatment of metastatic ovarian cancer in patients with disease that

is refractory to both paclitaxel and platinum-based chemotherapy regimens.

10:45 FDA Comments & ODAC Discussion Otis Brawley, M.D.

ODAC Discussant

11:30 Lunch

12:30 Open Public Hearing

COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

1:00 Sponsor Presentation James L’Italien, M.D. &

Gordon Bray, M.D.

Ligand Pharmaceuticals, Inc.

BLA 97-1325/STN 103767 Ontak (denileukin diftitox)

Indication: Treatment of persistent or recurrent cutaneous T-Cell lymphoma in

patients whose maligant cells express the CD25 component of the IL-2 receptor.

1:15 FDA Comments & ODAC Discussion Bruce Cheson, M.D.

ODAC Discussant

2:00 Break

COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

2:15 Sponsor Presentation James Pluda, M.D.

MedImmune Oncology, Inc.

NDA 20-221/S-002 Ethyol (amifostine)

Indication: Reduction in cumulative renal toxicity associated with repeated

administration of cisplatin in patients with advanced non-small cell lung cancer.

2:30 FDA Comments & ODAC Discussion Douglas Blayney, M.D.

ODAC Discussant

3:15 Estimated Time of Adjournment

March 13, 2003

8:00 Call to Order and Opening Remarks Donna Przepiorka, M.D., Ph.D.

Chair, ODAC

Introduction of Committee

Conflict of Interest Statement Johanna Clifford, M.S., RN, BSN

Executive Secretary, ODAC

8:15 Open Public Hearing

8:45 Sponsor Presentation Matthew L. Sherman, M.D.

Wyeth-Ayerst Laboratories, Inc.

NDA 21-174 Mylotarg (gemtuzumab ozogamicin)

Indication: Treatment of CD33 positive acute myeloid leukemia patients

in first relapse who are 60 years of age or older and who are not considered candidates

for cytotoxic chemotherapy.

9:00 FDA Comments & ODAC Discussion Donna Przepiorka, M.D., Ph.D

ODAC Chair

9:45 Break

COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

10:00 Sponsor Presentation Stephen Howell, M.D.

Skyepharma, Inc.

NDA 21-041 Depocyt (cytarabine liposomal injection)

Indication: Intrathecal treatment of lymphomatous meningitis

10:15 FDA Comments & ODAC Discussion Gregory Reaman, M.D.

ODAC Discussant

11:00 Lunch

12:00 Open Public Hearing

COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

12:30 Sponsor Presentation Daniel Vlock, M.D.

Pharmacia Corporation

NDA 21-156 Celebrex (celecoxib)

Indication: Reduction in number of adenomatous colorectal polyps in familial

adenomatous polyposis (FAP) patients.

12:45 FDA Comments & ODAC Discussion David Kelsen, M.D.

ODAC Discussant

1:30 Break

COI Statement and Introduction of New Participants Johanna Clifford, M.S., RN, BSN

1:45 Sponsor Presentation Craig Tendler, M.D.

Schering-Plough Corporation

NDA 21-029 Temodar (temozolomide)

Indication: Treatment of refractory anaplastic astrocytoma

2:00 FDA Comments & ODAC Discussion Sarah Taylor, M.D.

ODAC Discussant

2:45 Introduction of Questions and Committee Discussion

4:00 Estimated Time of Adjournment

Patient Representative (Voting):

Musa Mayer - New York, NY

Consultant (Voting):

Thomas Fleming, Ph.D.

Professor and Chair

Department of Biostatistics

University of Washington

Box 357232

Seattle, WA 98195

Acting Industry Representative (Non-Voting):

George Ohye

3 Heritage Hills Court

Skillman, NJ 08558-2340