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CI-1 Lenalidomide Myelodysplastic Syndromes (Revlimid ®, CC-5013, CDC-501) Graham Burton, MD Senior Vice President Regulatory Affairs Celgene Corporation.

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Presentation on theme: "CI-1 Lenalidomide Myelodysplastic Syndromes (Revlimid ®, CC-5013, CDC-501) Graham Burton, MD Senior Vice President Regulatory Affairs Celgene Corporation."— Presentation transcript:

1 CI-1 Lenalidomide Myelodysplastic Syndromes (Revlimid ®, CC-5013, CDC-501) Graham Burton, MD Senior Vice President Regulatory Affairs Celgene Corporation

2 CI-2 Lenalidomide Clinical Development Low/Int-1-Risk MDS MDS-001* (N = 43) Phase 1/2 Feb 2002 MDS-004 N = 162 Phase 3, initiated July 2005 MDS-005 N = 453 Phase 3, will open 2006 Completed trials Deletion 5q trials MDS-003 N = 148 Phase 2, initiated July 2003 MDS-002 N = 215 Phase 2, initiated July 2003 Non deletion 5q trials * List A, et al. N Engl J Med. 2005;352:549-557.

3 CI-3 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

4 CI-4 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

5 CI-5 Presentation Overview PreclinicalDavid Stirling, PhD Celgene Corporation MDS Classification and Prognosis John Bennett, MD University of Rochester Lenalidomide EfficacyAlan List, MD University of South Florida and H. Lee Moffitt Cancer Center and Research Institute Lenalidomide SafetyRobert Knight, MD Celgene Corporation Study ConclusionsAlan List, MD CloseGraham Burton, MD Celgene Corporation ModeratorRobert DeLap, MD Celgene Corporation

6 CI-6 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.


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