BLA #125019 ZEVALIN™ Kit

9/25/01


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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

Author: BishopP