CANCIDAS? (caspofungin acetate) for intravenous injection

2/5/01


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Table of Contents

CANCIDAS? (caspofungin acetate) for intravenous injection

Safety and Efficacy of CANCIDAS? (caspofungin acetate) in Invasive Aspergillosis

FDA Review Team for NDA 21-227

Outline

Proposed Labeling

Proposed Dosage Adjustments

Microbiology

Comparative Efficacy of Caspofungin and Amphotericin B in Granulocytic Rabbits with Invasive Pulmonary Aspergillosis

Pharmacokinetics

Pharmacokinetics

Outline

Clinical Studies: Invasive Aspergillosis

Clinical Studies: Mucosal Candidiasis

Protocol Summary Highlights for Studies 019 and 028/029

Study 019: Study Procedures

Study 028: Study Procedures

Exclusion Criteria

Study 019 and Study 028/029: Exclusion Criteria

Disease Definition

Disease Definition

Response to Prior Therapy

Study 019 and 028/029: Timing of Assessments

Study 019 and 028/029: Outcome Definitions

Expert Panel Assessment

Expert Panel Assessment

Study 019: Study Design

Study 019 and 028/029: Data Analysis

Study 019: Patient Accounting (May 1998- April 2000)

Study 028: Patient Accounting 1995-1998

Baseline Characteristics

Baseline Characteristics (cont.)

Baseline Characteristics (cont.)

Baseline Characteristics: Prior Therapy in Study 019 and 028/029

Duration of Prior/Standard Therapy

Total Treatment Duration for Current Aspergillosis Infection

Applicant Clinical Efficacy Rates

Complete Responses and Relapse

Complete Response to Caspofungin

Clinical Efficacy Rates by Baseline Risk

Clinical Efficacy Rates by Geographic Region

Clinical Efficacy Rates by Total Duration of Treatment

Central nervous system involvement in patients with IA

Post-Caspofungin Therapy

Comparability of the Historical Control (028/029) and the Cancidas™-treated Patients (019)

Information Bias

Bias from Secular Trends in Diagnosis and/or Treatment

Selection Bias

Summary of Comparability

Outline

Safety Database

Drug Exposure

Overall Caspofungin Safety in Clinical Studies

Drug-Related Adverse Events

LFT Elevations : Clinical Studies Relative Elevation > 3x ULN

Potential Safety Issues

Summary

PPT Slide

Author: CDER USER