Table of Contents
FDA Review : Cisplatin / Epinephrine Gel (CEG) in the Treatment of Head and Neck Cancer
Outline of FDA Presentation
FDA Cisplatin-Gel NDA Review Team
Requirements for New Drug Approval
Basis of Oncology Drug Approvals
Full Approval Based on RR or other Tumor Endpoints
Oncology Drug Approvals Supported by RR or TTP
Approvals Based Primarily on Tumor-Related Symptoms
FDA meetings with Applicant
FDA Reservations about Protocol
FDA Clinical Review
Study Design
Key Design Features
Study Design
Submitted Clinical Data
Clinical Endpoints
Dosing Regimen
Dosing Regimen
Study Design
Study Design
Study 414 Results
Study 514 Results
Study 414 & 514 Results
Study 414 Results
Study 514 Results
Study 414 Results Reason for Termination
Study 514 Results Reason for Termination
Study 414 Results
Study 514 Results
Study 414 & 514 Results
Study 414 & 514 Results Causes of Dosing Errors
Study 414 Results Actual Dose vs. Planned Dose
Study 514 Results Actual Dose vs. Planned Dose
Study 414 & 514 Results Internal Consistency Concerns
Study 414 & 514 Results Local Toxicity Parameters
Study 414 & 514 Safety
Study 414 & 514 Summary
Study 414 & 514 Summary
FDA Statistical Review
Areas of Major Statistical Problems
Objective MTT Response
Objective MTT Response - Study 414
Objective MTT Response -Study 514
Graph of Survival Data
Clinical Patient Benefit
Patient Benefit
Patient Benefit Algorithm
Clinical Benefit - Study 414 and Study 514: Sponsor Analyses
Pooled Analysis Not Acceptable
Treatment Received - Study 414
Treatment Received - Study 514
Preventive Goals - Investigator Assessment
Patient preventive Benefit
Investigator Assessment of Change in Palliative Treatment Goal Score Study 414
Investigator Assessment of Change in Palliative Treatment Goal Score Study 514
Patient or Investigator Palliative Benefit Assessment - Study 414 FDA Analyses
Patient or Investigator Palliative Benefit Assessment - Study 514 FDA Analyses
Clinical Patient Benefit - FDA Analyses
Clinical Patient Benefit
Association Between Tumor Response and Patient Benefit - Study 414 Sponsor Analysis
Association Between Tumor Response and Patient Benefit - Study 514 Sponsor Analysis
Association Between Tumor Response and Patient Benefit - Study 414 FDA Analysis
Association Between Tumor Response and Patient Benefit - Study 514 FDA Analysis
Association Between Tumor Response and Patient Benefit
Summary
Summary of FDA Findings
Objective Response Rate
Primary palliative goal
Issues to consider
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