Table of Contents
Ibritumomab Tiuxetan (Zevalin™) Radioimmunotherapy of Non-Hodgkin’s Lymphoma
Presentation Agenda
Zevalin™ (ibritumomab tiuxetan):Proposed Indication
Non-Hodgkin’s Lymphoma
Zevalin Regimen
IDEC
Clinical Basis for BLA
FDA Agreements
Zevalin™ (ibritumomab tiuxetan):Summary
IDEC Investigators
IDEC Investigators (cont.)
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Ibritumomab Tiuxetan (Zevalin™) Radioimmunotherapy of Non-Hodgkin’s Lymphoma
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Treatment of Relapsed or Refractory LG/F/T NHL
Toxicities of Commonly Used Regimens
Treatment of Relapsed or Refractory LG/F/T NHL
Rationale for Radioimmunotherapy in NHL
Critical Factors for Successful RIT
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Zevalin Phase I and I/II Conclusions
Zevalin Phase I/II Study (N = 51)
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Imaging and Dosimetry
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Disease Status (cont.)
Response Assessment Protocol-Defined Response Criteria
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Response Assessment International Workshop Response Criteria
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Zevalin vs Prior Therapy Analysis
Zevalin vs Prior Rituximab or Last Chemotherapy (N = 54)
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Phase III Nonhematologic AEs (N = 143)
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Absolute Neutrophil Counts (N = 349)
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Duration of Hematologic Toxicity
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Immunology
MDS/AML
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Mortality (N = 349)
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Subsequent Bone Marrow Transplantation
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Summary
Summary (cont.)
Conclusion
Presentation Agenda
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