Oncologic Drugs Advisory
Committee
Slides
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
Lenalidomide Nonclinical Overview David Stirling,
Ph.D.
Chief
Scientific Officer
MDS Classification and Prognosis John M.
Bennett, M.D., Hematomorphologist
University
of
Chair,
MDS Foundation
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
Lenalidomide Safety Assessment Robert Knight, M.D.
Vice
President, Clinical Research – Oncology
Conclusions Graham
Burton, M.D.
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
Open
Public Hearing Speakers
Questions to the Committee
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,
Chair,
Leukemia Committee, CALGB
Role in Treatment William
Carroll, M.D.
Director,
Pediatric Oncology, NYU
Chair,
ALL Committee, COG
FDA
Presentation
Arranon (nelarabine) FDA review Martin
Cohen, M.D.
Medical
Officer, Division of Drug Oncology Products, FDA
Open Public Hearing Speakers
Questions to the Committee