Table of Contents
Trastuzumab [Genentech Inc.] Labeling Supplement to Include FISH Testing as a Method to Select Patients for Treatment
Objective of This sBLA
Background: Trastuzumab
Background: Trastuzumab
Background: Trastuzumab
Background: Trastuzumab
Background: Trastuzumab
Background: Trastuzumab
Postmarketing Commitment
Postmarketing Commitment
Regulatory Timeline for FISH sBLA
Regulatory Timeline for FISH sBLA
Regulatory Timeline for FISH sBLA
FDA Perception of the Field of HER2 Testing
FDA Perception of the Field of HER2 Testing
FISH sBLA: Nature of the Clinical Outcome Data
FISH sBLA: Nature of the Clinical Outcome Data
FISH sBLA: Studies Conducted
Overview of Studies
FISH Testing Results: Success/Failure Rates
FISH Testing Results: Success/Failure Rates
FISH Testing Results: Success/Failure Rates
FISH Testing Results: Comparison of LabCorp and Press Labs
FISH Testing Results: Comparison of LabCorp and Press Labs
FISH Testing Results Concordance Study
FISH Testing Results Concordance Study
FISH Testing Results Concordance Study
FISH Testing Results Clinical Outcome Study
FISH Testing Results Clinical Outcome Study
H0648g Time to Progression Trastuzumab +Chemo vs Chemo
H0648g Time to Progression Trastuzumab +Chemo vs Chemo
H0648g Time to Progression, 3+
H0648g Time to Progression, 2+
H0648g Time to Progression, FISH (+)
H0648g Time to Progression, FISH (-)
H0648gTime to Progression,FISH (+)/3+
H0648g Time to Progression, FISH (+)/2+
H0648g Time to Progression, FISH (-)/3+
H0648g Time to Progression, FISH (-)/2+
H0648g Time to Progression Trastuzumab +Chemo vs Chemo
H0648g Time to Progression Trastuzumab +Chemo vs Chemo
PPT Slide
H0648g Overall Survival Trastuzumab + Chemo vs Chemo
H0648g Overall Survival, 3+
H0648g Overall Survival, 2+
H0648g Overall Survival, FISH (+)
H0648g Overall Survival, FISH (-)
H0648g Overall Survival, FISH (+)/3+
H0648g Overall Survival, FISH (+)/2+
H0648g Overall Survival, FISH (-)/3+
H0648g Overall Survival, FISH (-)/2+
H0648g Overall Survival Trastuzumab + Chemo vs Chemo
H0648g Overall Survival Trastuzumab + Chemo vs Chemo
H0648g Overall Response Rate Trastuzumab + Chemo vs Chemo
H0649g Overall Response Rate
H0649g Overall Response Rate Single Agent Trastuzumab
Conclusions
Conclusions
Conclusions
Conclusions
Conclusions
Conclusions
Potential Questions to Address Postmarketing
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