Table of Contents
sNDA 20-726 Letrozole (Femara®)
Letrozole Pivotal Trial
Comparator Treatment
Trial Objectives
Eligibility
Tumor Evaluations
Response Determination
Patients Studied
Study Patients
Study Patients
Patient Characteristics
Efficacy
Median Treatment Duration
Time to Progression
Response Rate
Response Duration
Response by Dominant Site
Response by Receptor Status
Performance Status Improvement (Exploratory FDA Analysis)
Performance Status Improvement Initial PS 50-70
Serious Vascular Adverse Events
Serious Adverse Events
Early Therapy Discontinuation
AE’s Special Populations ____________________
Efficacy Summary
Safety Summary ______________________
Approval Based on a Single Study
Review Team Recommendation __________________________
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