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Food and Drug Administration

Oncologic Drugs Advisory Committee Meeting  

Slides Presented at Meeting


September 6, 2006


NDA 21-874 - Genasense

Sponsor Presentation

(ppt) (htm)





Relapsed Refractory CLL




Clinical Efficacy/Safety      






[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
(ppt) (htm)



NDA 21-874

Robert Kane, M.D., Medical Officer

Division of Drug Oncology Products



Open Pulic Hearing (ppt) (htm)



Questions for the Committee

(ppt) (htm)



NDA 20-287 Fragmin

Sponsor Presentation (ppt) (htm)







Background on VTE and Cancer



CLOT Study Design & ITT Results




CLOT Study Further Analyses






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

(ppt) (htm)

(ppt) (htm)


Frank Burroughs & Steve Walker

Abigail Alliance

Meeting Questions

(ppt) (htm)



September 7, 2006



NDA 21-660 Abraxane

Sponsor Presentation

Abraxane®: Background & PK/Safety

Comparisons with Taxol®

(ppt) (htm)

Results of the Phase 3 Clinical Trials

of Abraxane® vs. Taxol® in Metastatic

Breast Cancer

(ppt) (htm)

Perspectives on the use of Abraxane®

In Node-positive Breast Cancer

(ppt) (htm)

[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






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)



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