Alemtuzumab BLA committee

2/1/01


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Table of Contents

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Alemtuzumab BLA committee

CD52 Expression

Expression on Other Cell Types

Antibody History

CAMPATH-1H (Alemtuzumab)

History of Submission

History of Submission

Pharmacokinetics Comment

Clinical Trials

Supporting Trials

Study Design

Study Design

Study Design

Study Design

Study Design

Study Design

Demographics

Rai Staging System

Rai Stage

Eligibility

Disposition

Efficacy Information

Responses, Response Rate

Response Measures

Responder Characteristics

Other Efficacy Parameters

Other Efficacy Parameters

Other Efficacy Parameters

Resolution in Symptoms in Responders

Safety Data

Dose Delays: > Seven Days

Reasons for Dose Delays > Seven Days

Mortality

Drug Related Causes of Death

Discontinuations

Serious Adverse Events

211: Analysis of Heme / Infectious SAEs, Stage I / II

211: Analysis of Hem and Infectious SAEs, Stage III / IV

Opportunistic Infections

Types of Serious OIs

Infusional Toxicities:All Grades

Infusional Toxicities: Gr. 3/4

Premedications

New Malignancies / Transformations

Hematological Toxicity

211 Heme Toxicity: Hgb

211 Heme Toxicity: Hemoglobin

211Hem Toxicity : Neutrophils

211 Hem Toxicity: Neutrophils

211 Heme Toxicity : Platelets

Heme Toxicity: 211- Platelets

211 Hem Toxicity: Two Month Follow-Up

Blood Product Usage

CD4+ Counts < 200/?l

SUMMARY

SUMMARY

SUMMARY

SUMMARY

SUMMARY

Author: CBER