FDA Review : Cisplatin / Epinephrine Gel (CEG) in the Treatment of Head and Neck Cancer

9/25/01


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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

Author: The Williams'