FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Oncologic Drugs
Advisory Committee
Slides
Presented
The
committee will discuss New Drug Application (NDA) 21-115 Combidex® (ferumoxtran-10)
Advanced Magnetics, Incorporated, proposed indication for intravenous administration as a Magnetic
Resonance Imaging (MRI) contrast agent to assist in the differentiation of
metastatic and non-metastatic lymph nodes in patients with confirmed primary
cancer who are at risk for lymph node metastases.
Advanced Magnetics, Inc.
Combidex, Introduction and
Indication Mark C. Roessel
[HTML] [PPT] Vice
President Regulatory Affairs
Advanced Magnetics, Inc.
Mechanism
of Action, Combidex Mukesh Harisinghani, M.D.
Appearance on MR Images Department of Radiology
[HTML] [PPT]
Efficacy
Data from Phase III Clinical Studies William Goeckeler, Ph.D.
[HTML] [PPT] Senior Vice
President Development
Cytogen
Corporation
Safety
Data from Clinical Trial Gerald
Faich, M.D.
[HTML] [PPT] President
Pharmaceutical Safety Associates
Clinical
Utility of Combidex and Various Cancers Jelle
O. Barentsz, M.D.
[HTML] [PPT] Professor of
Radiology
FDA Presentation
Efficacy & Safety of
Combidex (NDA 21-115) Zili Li, M.D.,
MPH, Medical Team Leader
[HTML]
[PPT] Division of
Medical Imaging and Radiopharmaceutical Drug Products,
FDA
Open
Public Hearing Speakers
The committee will
discuss prostate cancer endpoints as a follow up to the June 2004 FDA Workshop.
A
Regulatory Perspective of End Points to Bhupinder Mann, MBBS, Medical
Officer
Measure
Safety and Efficacy of Drugs: Division of Oncology Drug Products,
FDA
[HTML]
[PPT] Hormone
Refractory Prostate Cancer
Towards a Consensus in Measuring Outcomes in Derek
Raghavan, M.D., Ph.D.
New
Agents for Prostate Cancer Chairman,
Department of Hematology and Medical Oncology
[HTML] [PPT]
NCI Prostate Cancer
Treatment Trial Portfolio Alison Martin, M.D.
[HTML] [PPT] Clinical
Investigations Branch, Cancer Therapy Evaluation
Program,
Division of Cancer Treatment & Diagnosis,
National Cancer
Institute, National Institutes of Health
Toward an Endpoint for Accelerated Approval Howard
Scher, M.D., Chief, Genitourinary Onc. Service
for Clinical Trials in
Castration Resistant/Hormone
]Refractory
Prostate Cancer
Design
of Clinical Trials for Select Patients With Anthony
D’Amico, M.D., Ph.D.
a Rising PSA Following
Primary Therapy Professor and Chair of Genitourinary
Radiation Oncology
[HTML] [PPT] Brigham
& Women’s Hospital, Dana Farber Cancer Institute
Open
Public Hearing Speakers
Committee
Discussion