Oncologic Drugs Advisory Committee Meeting  

Slides Presented at Meeting

September 6, 2006

MORNING SESSION

NDA 21-874 - Genasense

Sponsor Presentation

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Introduction

Relapsed Refractory CLL

Clinical Efficacy/Safety      

Risk/Benefit           

Conclusions

[Backup Slides] (ppt) (htm)

Genta Incorporated

Loretta M. Itri, M.D.

President, Pharmaceutical Development and

Chief Medical Officer

Michael Keating, M.D.

Professor of Medicine

M.D. Anderson Cancer Center

Loretta M. Itri, M.D.

Susan O’Brien, M.D.

Professor of Medicine, Leukemia

MD Anderson Cancer Center

Loretta M. Itri, M.D.

FDA Presentation
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NDA 21-874

Robert Kane, M.D., Medical Officer

Division of Drug Oncology Products

OODP, CDER, FDA

Open Pulic Hearing (ppt) (htm)

Questions for the Committee

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AFTERNOON SESSION

NDA 20-287 Fragmin

Sponsor Presentation (ppt) (htm)

Introduction

Background on VTE and Cancer

CLOT Study Design & ITT Results

CLOT Study Further Analyses

Summary/Conclusions

Pfizer Incorporated

Connie Newman, M.D.,

Therapeutic Area Head CVMED

Worldwide Regulatory Affairs and Quality Assurance

Craig Eagle, M.D., Senior Director

Head of Worldwide Medical Oncology  

Agnes Y. Y. Lee, M.D., M.Sc., FRCPC

Associate Professor, Medicine, McMaster University Hamilton Health Sciences Henderson Hospital Hamilton, ON

Craig Eagle, M.D

Craig Eagle, M.D.

FDA Presentation (ppt) (htm)

Fragmin for treatment of VTE in cancer patients

NDA 21-986

Andrew Dmytrijuk, M.D., Medical Officer

of Medical Imaging and Hematology Products, OODP, CDER, FDA

Open Pulic Hearing

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Frank Burroughs & Steve Walker

Abigail Alliance

Meeting Questions

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September 7, 2006

MORNING SESSION

NDA 21-660 Abraxane

Sponsor Presentation

Abraxane®: Background & PK/Safety

Comparisons with Taxol®

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Results of the Phase 3 Clinical Trials

of Abraxane® vs. Taxol® in Metastatic

Breast Cancer

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Perspectives on the use of Abraxane®

In Node-positive Breast Cancer

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[Backup] (ppt) (htm)

Abraxis Bioscience Inc.

Michael J. Hawkins, M.D.

 Chief Medical Officer

William J. Gradishar, M.D., FACP

 Professor of Medicine

 Northwestern University

Clifford A. Hudis, M.D.

Chief, Breast Cancer Medicine Service

Memorial Sloan Cancer Center

FDA Presentation (ppt) (htm)

Proposal for Abraxane Use in Adjuvant Use in Adjuvant Breast Cancer

A Pharmacokinetic Comparison

of Abraxane and Taxol

Trial Design Considerations

NDA 21-660

Patricia Cortazar, M.D., Medical Officer

DODP, OODP, CDER, FDA

Brian Booth, Ph.D., Clinical Pharmacology Acting Team, Leader for Oncology Drugs, Division of Clinical, Pharmacology 5, Office of Clinical Pharmacology, CDER, FDA

Rajeshwari Sridhara, Ph.D., Statistical Team Leader for Oncology Drugs, Division of Biometrics V, Office of Biostatistics, CDER, FDA

Open Public Hearing (ppt) (htm)

Questions (ppt) (htm)