Single Patient Use of Investigational Anticancer Agents:

2/1/01


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Table of Contents

Single Patient Use of Investigational Anticancer Agents:

Rising Public Expectations Make Earlier Access Necessary

Single Patient INDs Provide Needed Access to Promising Experimental Anticancer Compounds:

Initiating the Single Patient IND

Additional Treatment Approaches Are Needed

AstraZeneca Experience ZD1839 (Iressa™)

PPT Slide

Initial Plan: Initiate Phase III Trials

Expanded Access Program (EAP) Previous Precedents

Principles: Iressa Expanded Access Program (EAP)

Registration Is The Best Route To Expanded Access

The Iressa (EAP): Initial Steps

Iressa EAP Protocol

EAP Challenges

EAP Concerns

EAP Opportunities

Implications for the Future

FDA Guidance Needed

Thank You

Author: Mark Krueger