文档介绍：IRESSA® (ZD1839) Monotherapy for Non-Small Cell Lung Cancer (NSCLC)
Oncologic Drugs
mittee Meeting
September 24, 2002
ONCOLOGY
IRESSA® Introduction
e Blackledge, MD
Clinical Vice President, Oncology
AstraZeneca Pharmaceuticals
IRESSA® Agenda for Today’s Meeting
Introduction e Blackledge, MD
Refractory NSCLC Frances A. Shepherd, MD
Clinical efficacy Ronald B. Natale, MD
Safety profile Alan B. Sandler, MD
Summary e Blackledge, MD
3
Experts Available for Q&A
Jose Baselga, MD
Chairman, Medical Oncology
Vall d'Hebron University Hospital
Barcelona, Spain
David Cella, PhD
Director, Center on es Research and Education
Northwestern University
Evanston, IL
Gary Donaldson, PhD
Professor, Department of Anesthesiology
University of Utah School of Medicine
Salt Lake City, UT
Mark Kris, MD
Chief, Thoracic Oncology
Memorial Sloan-Kettering Cancer Center
New York, NY
Thomas Lynch, MD
Associate Professor of Medicine
Massachusetts General Hospital
Boston, MA
4
Experts Available From AstraZeneca
Steve Averbuch, MD
Andrea Kay, MD
David McKillop, PhD
Judith Ochs, MD
Graham Richmond, MSc
Mark Scott, PhD
Mark Steinberg, MD
Helen Swaisland, BSc
Alan Wakeling, PhD
Michael Wolf, MSc
5
IRESSA® for 3rd-Line NSCLC
High unmet need
Thousands of patients each year
Disease of symptoms
IRESSA
Unprecedented activity in target population
Symptom control
Excellent tolerability
6
Demonstration of the Role of IRESSA®
IRESSA® 250 mg po daily can be used in the 3rd-line treatment of patients with locally advanced or metastatic non-small cell lung cancer.
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How Did We Get Here? IRESSA®
Molecular targeted agents 1990 discovery program
ZD1839 molecule discovered 1994
Healthy volunteer trials 1997
8
myc
cyclin D1
Jun
Fos
R
R
R
R
EGFR Signal Transduction in Tumor Cells
K
K
K
K
Gene transcription and
cell cycle progression
CI-9
9
Metastasis
Angiogenesis
myc
cyclin D1
Jun
Fos
R
R
EGFR Signal Transduction in Tumor Cells
K
K
R
K
R
K
Gene transcription