Lenalidomide Myelodysplastic Syndromes (Revlimid

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Lenalidomide Myelodysplastic Syndromes
(Revlimid, CC-5013, CDC-501)

• Graham Burton, MD
• Senior Vice President Regulatory Affairs
  Celgene Corporation

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Lenalidomide Clinical DevelopmentLow/Int-1-Risk
MDS
List A, et al. N Engl J Med. 2005352549-557.
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Lenalidomide Robust Phase 2 Results

• Well-characterized population
• Low/Int-1-Risk, del 5q patients
• Conventional cytogenetic testing
• Largest prospective clinical study of del 5q MDS
• Significant clinical benefit
• Durable resolution of refractory anemia (67)
• Significant rise in hemoglobin
• Cytogenetic response and remissions
• Marrow normalization and improvements
• Well-characterized, manageable AEs

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Lenalidomide

• Proposed label
• Lenalidomide is indicated 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 cytogenetic abnormalities

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Presentation Overview
Preclinical David Stirling, PhDCelgene Corporation
MDS Classification and Prognosis John Bennett, MDUniversity of Rochester
Lenalidomide Efficacy Alan List, MDUniversity of South Florida and H. Lee Moffitt Cancer Center and Research Institute
Lenalidomide Safety Robert Knight, MDCelgene Corporation
Study Conclusions Alan List, MD
Close Graham Burton, MDCelgene Corporation
Moderator Robert DeLap, MDCelgene Corporation
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External Advisors
Gordon Dewald, PhD Professor of Laboratory Medicine and Medical Genetics Mayo Clinic
Janice Gabrilove, MD Professor of Medicine Mount Sinai School of Medicine
Mildred Christian, PhD Consultant Argus International, Inc.