Oncologic Drugs Advisory Committee

Slides

 

September 14, 2005 AM Session

 

The committee will discuss New Drug Application (NDA) 21-880, proposed trade name Revlimid (lenalidomide), Celgene Corporation, proposed indication for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cyogenetic abnormalities.

 

Sponsor Presentation Celgene Corporation

 

Introduction Graham Burton, M.D.

Senior Vice President, Regulatory Affairs, Drug Safety and

Project Management

[HTML] [PPT]

 

Lenalidomide Nonclinical Overview David Stirling, Ph.D.

Chief Scientific Officer

[HTML] [PPT]

 

MDS Classification and Prognosis John M. Bennett, M.D., Hematomorphologist

University of Rochester Medical Center

Chair, MDS Foundation

[HTML] [PPT]

 

Lenalidomide Efficacy Alan List, M.D. Professor of Medicine and Oncology

Chief, Division of Malignant Hematolgy

H. Lee Moffitt Cancer Center & Research Institute

University of South Florida College of Medicine

[HTML] [PPT]

 

Lenalidomide Safety Assessment Robert Knight, M.D.

Vice President, Clinical Research Oncology

[HTML] [PPT]

 

Conclusions Graham Burton, M.D.

[HTML] [PPT]

 

FDA Presentation

 

Revlimid (lenalidomide) FDA review Maitreyee Hazarika, M.D.

Medical Officer, Division of Drug Oncology Products, FDA &

Kimberly Benson, Ph,D.

Pharmacology/Toxicology Reviewer

Division of Drug Oncology Products, FDA &

Edvardas Kaminskas, M.D.

Medical Officer, Division of Drug Oncology Products, FDA

[HTML] [PPT]

 

Open Public Hearing Speakers

[HTML] [PPT]

 

Questions to the Committee

[HTML] [PPT]

 

The committee will discuss NDA 21-877, proposed trade name Arranon (nelarabine) Injection, GlaxoSmithKline, proposed indication for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed with at least two chemotherapy regimens.

 

Sponsor Presentation GlaxoSmithKline

Disease Overview Stephen Sallan, M.D.

Professor of Pediatrics, Harvard

Chief of Staff, Dana-Farber

 

Efficacy Summary Richard Larson, M.D.

Professor of Medicine, University of Chicago

Chair, Leukemia Committee, CALGB

 

Role in Treatment William Carroll, M.D.

Director, Pediatric Oncology, NYU

Chair, ALL Committee, COG

[HTML] [PPT] [PDF]

 

FDA Presentation

Arranon (nelarabine) FDA review Martin Cohen, M.D.

Medical Officer, Division of Drug Oncology Products, FDA

[HTML] [PPT]

 

Open Public Hearing Speakers

[HTML] [PPT]

 

Questions to the Committee

[HTML] [PPT]