Food and Drug Administration
Center for
Drug Evaluation and Research
Oncologic Drugs Advisory
Committee
Meeting Agenda
74th
Meeting Holiday Inn
Introduction of Committee
Ramzi Dagher, M.D., Medical Officer
Division of Oncology Drug Products
Center for Drug Evaluation & Research Division of Oncologic Drugs
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.
ODAC Discussant
COI
Statement & Introduction of New Participants Johanna
Clifford, M.S., RN, BSN
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.
ODAC Discussant
COI Statement &
Introduction of New Participants Johanna
Clifford, M.S., RN, BSN
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.
ODAC Discussant
COI Statement &
Introduction of New Participants Johanna
Clifford, M.S., RN, BSN
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.
ODAC Discussant
Conflict of Interest Statement Johanna Clifford, M.S., RN, BSN
Executive Secretary, ODAC
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.
ODAC Chair
COI Statement & Introduction of New
Participants Johanna Clifford, M.S., RN, BSN
Skyepharma, Inc.
NDA
21-041 Depocyt (cytarabine liposomal injection)
Indication:
Intrathecal treatment of lymphomatous meningitis
ODAC
Discussant
COI
Statement & Introduction of New Participants Johanna
Clifford, M.S., RN, BSN
Pharmacia Corporation
NDA 21-156 Celebrex (celecoxib)
Indication:
Reduction in number of adenomatous colorectal polyps in familial
adenomatous polyposis
(FAP) patients.
ODAC Discussant
COI Statement and
Introduction of New Participants Johanna Clifford, M.S., RN, BSN
Schering-Plough
Corporation
NDA 21-029 Temodar (temozolomide)
Indication:
Treatment of refractory anaplastic astrocytoma
ODAC Discussant
Patient
Representative (Voting):
Musa Mayer -
Consultant
(Voting):
Thomas Fleming,
Ph.D.
Professor and Chair
Department of
Biostatistics
Acting Industry
Representative (Non-Voting):
George Ohye