Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

Slides Presented

March 3, 2005:

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]                                                   Massachusetts General Hospital


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

                                                                        University Hospital Nijmegen, Netherlands


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             



10:45 a.m.         Committee Discussion

 [HTML]  [PPT]

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]                                                               Cleveland Clinic Taussig Cancer Center


 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                        Sidney Kimmel Center for Prostate and Urologic Cancers

]Refractory Prostate Cancer                                           Memorial Sloan Kettering Cancer Center



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

                                                                                    Harvard Medical School


Open Public Hearing Speakers



Committee Discussion