Trastuzumab [Genentech Inc.] Labeling Supplement to Include FISH Testing as a Method to Select Patients for Treatment

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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

Author: jerian