sNDA # 20-637 GLIADEL® WAFER (Polifeprosan 20 with Carmustine Implant) APPLICANT: GUILFORD PHARMACEUTICALS

1/3/02


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Table of Contents

sNDA # 20-637 GLIADEL® WAFER (Polifeprosan 20 with Carmustine Implant) APPLICANT: GUILFORD PHARMACEUTICALS

FDA Presentation

Regulatory History

Regulatory History

New Indication

New Indication

Clinical Review Study T-301

GLIADEL Wafer Proposed Indication

Study Objectives

Phase 3 Trial Study T-301

Study Enrollment

Baseline Characteristics

Tumor Histology

Protocol-Specified Treatments • Radiation Therapy • Chemotherapy • Other Treatment for Disease Progression

Chemotherapy

Other Treatment for PD

Efficacy Results

Primary Efficacy Endpoint Overall Survival

Primary Efficacy Analysis: Statistical Issues

Primary Efficacy Analysis

Overall Survival Curves for Study T-301

Primary Efficacy Analysis (Protocol Specified OS ITT Analysis)

Secondary Analysis: Stratified Log-rank Tests (Protocol Specified OS ITT Analysis)

Survival Analysis: Cox Model Adjusting for Covariates

Survival Analysis Summary

Issues

Randomization List for All U.S. Sites

Exploratory Analysis: Log-rank Stratified by CENTER

Primary Efficacy Analysis: Summary of Statistical Issues

Secondary Endpoints

Secondary Endpoint: Survival in GBM

Secondary Endpoint: 1-Yr Survival

Secondary Endpoint: Progression-Free Survival

Secondary Endpoint: Time to KPS Deterioration

Secondary Endpoint: Time to KPS Deterioration (Death not account as an event)

Secondary Endpoint: QoL

Time to Neuroperformance Deterioration (ITT Population)

Time to Neuroperformance Deterioration (ITT Population)

Safety Results

Cause of Deaths in the First 30 Days of Randomization

Local Complications

Review Issues

Single Trials: Evidence of Effectiveness*

T-301: Single Trial

Can the trials presented in 1996 be considered confirmatory?

Primary Basis of Approval: North American Trial

North American Trial

Overview of Median Survival in ITT Population

Supportive: Scandinavian Trial

Scandinavian Trial

Summary of Review Issues

Questions for the Committee

Questions….

PPT Slide

Author: CDER.USER