Table of Contents
BLA #125019 ZEVALIN™ Kit
Presentation Outline
BLA #125019 Regulatory History
ZEVALIN™ BLA Contents
Proposed Indication
Regulatory History
Regulatory History
Efficacy
ZEVALIN™ Therapy Development
Efficacy Study Trial 106-04
106-04 Primary Efficacy Analysis
106-04 Subgroup Analysis ORR
106-04 Duration of Response (DR)
106-04 Subgroup Analysis Duration of Response
Supportive Study Trial 106-06
Trial 106-06
106-06 Primary Efficacy Analysis
106-06 Duration of Response*
ZEVALIN vs. Prior Rituximab Therapy Analysis
106-06 Duration of Response
Efficacy FDA Assessment
Safety
Hematologic Toxicity Within First 90 Days (N=392)
Grade 3-4 ANC N=214/392 (55%)
Immunologic Effects
Infections
Grade 3-4 PLT N=224/392 (57%)
Study 106-05: Grades 3-4 PLT N=26/30 (87%)
Incidence of Bleeding
Exploratory Analyses Cytopenias Risk Factors
Non Cytopenic AEs Per Patient Incidence (N=358)
Common Non-Heme AEs Study 106-04
Notable AEs (All Grades) Study 106-04
Secondary Malignancies n=349
HAMA/HACA Response (N=211)
Deaths
Safety FDA Assessment
Safety FDA Assessment
Dosimetry & Biodistribution
Whole Body Biodistribution Imaging
Normal Organ Dosimetry
Radiation Absorbed Dose Notable Organs
GI Toxicity (All Grades)
“Worst Case” Scenarios
Dosimetry-Biodistribution FDA Assessment
Dosimetry-Biodistribution FDA Assessment
Conclusions
Summary
Summary
Summary
Questions to the Committee
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