Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

Meeting Agenda

March 12-13, 2003

74^th Meeting

Versailles Ballroom

Holiday Inn

Bethesda, MD

Please note the agenda times listed are subject to change as the meeting progresses

March 12, 2003

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

Chair, ODAC

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

Introduction of Committee Executive Secretary, ODAC

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

9:15 Sponsor Presentation Johnson & Johnson Pharmaceutical

Research & Development, LLC

NDA 50-718 Doxil (doxorubicin hydrochloride)

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

10:15 Break

10:30 COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

Sponsor Presentation Johnson & Johnson, Pharmaceutical

Research& Development, LLCLtd.

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

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

is refractory to both paclitaxel and platinium-based chemotherapy regimens

10:45 FDA Comments & ODAC Discussion

11:30 Lunch

12:30 Open Public Hearing

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

Executive Secretary, ODAC

1:00 Sponsor Presentation Ligand Pharmaceuticals

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

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

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

1:15 FDA Comments & ODAC Discussion

2:00 Break

2:15 COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

Executive Secretary, ODAC

Sponsor Presentation 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 non small cell lung cancer.

2:30 FDA Comments & ODAC Discussion

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 Wyeth-Ayerst Laboratories, Inc.

NDA 21-174 Mylotarg (gemtuzumab ozogamicin)

Indication: Treatment of patients with CD33 positive acute myeloid

leukemia is first relapse who are 60 years of age or who are not considered

candidates for cytotoxic chemotherapy

9:00 FDA Comments & ODAC Discussion

9:45 Break

10:00 COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

Executive Secretary, ODAC

Sponsor Presentation SkyePharma, Inc.

NDA 21-041 Depocyt (cytarabine)

Indication: Intrathecal treatment of lymphomatous meningitis

10:15 FDA Comments & ODAC Discussion

11:00 Lunch

12:00 Open Public Hearing

12:30 COI Statement & Introduction of New Participants Johanna Clifford, M.S., RN, BSN

Executive Secretary, ODAC

Sponsor Presentation Pharmacia Corporation

NDA 21-156 Celebrex (celecoxib)

Indication: Reduction in number of adenomatous colorectal polyps in familial

adenomatous polyposis patients.

12:45 FDA Comments & ODAC Discussion

1:30 Break

1:45 COI Statement and Introduction of New Participants Johanna Clifford, M.S., RN, BSN

Executive Secretary, ODAC

Sponsor Presentation Schering-Plough Corporation

NDA 21-029 Temodar (temozolomide)

Indication: Treatment of adult patients with refractory anaplastic astrocytoma

2:00 FDA Comments & ODAC Discussion

2:45 Introduction of Questions and Committee Discussion

4:00 Estimated Time of Adjournment