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
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