Zometa for Patients with Bone Metastases

2/1/02


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Table of Contents

Zometa for Patients with Bone Metastases

FDA Clinical Review Team

Outline of Presentation

Proposed Zometa Indication

Efficacy requirement

FDA-Applicant Design Assumptions

SRE Analyses

SRE Analyses

Critical Questions Myeloma and Breast Cancer

Critical Questions Prostate Cancer (Study 039)

Critical Questions Other Solid Tumors (Study 011)

Study 010 Design

Study 010 Design

PPT Slide

PPT Slide

Determing Zometa Effect

Constancy Assumption

Differences Between Historical Population and NDA Population

Evaluating Assumption (1)

Evaluating Assumption (2)

Evaluating Assumption (3)

Myeloma And Breast Cancer FDA Conclusion

PPT Slide

Questions to ODAC

Critical Questions: Myeloma and Breast Cancer

Critical Questions Prostate Cancer (Study 039)

Critical Questions Other Solid Tumors (Study 011)

Efficacy requirement

Author: CDER USER