sNDA 20-726 Letrozole (Femara®)


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Table of Contents

sNDA 20-726 Letrozole (Femara®)

Letrozole Pivotal Trial

Comparator Treatment

Trial Objectives


Tumor Evaluations

Response Determination

Patients Studied

Study Patients

Study Patients

Patient Characteristics


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 __________________________

Author: cohenm