Zometa for Prostate Cancer Bone Metastases

2/1/02


Click here to start


Table of Contents

Zometa for Prostate Cancer Bone Metastases

PPT Slide

Overview of Prostate Cancer Trial

Proportions of Patients with SREs: Protocol defined Primary Endpoint

Time To First Event: FDA preferred Primary Endpoint

PPT Slide

Secondary Endpoints - 039

Exploratory analysis

Pooled analysis: Zometa vs. Placebo - 039 exploratory analysis

PPT Slide

Proportions (%) of Patients with any SRE in Blastic Metastasis in Solid Tumor Trial-011 exploratory analysis - support for prostate cancer study

PPT Slide

Early discontinuations were not the cause of inconsistency

Summary of Results Prostate Cancer Trial - 039

FDA Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products

FDA Guidance for Industry FDA approval of New Cancer Treatment Uses for Marketed Drug and Biological Products

Summary of Issues

PPT Slide

Zometa for Bone Metastases of Solid Tumors other than Breast Cancer and Prostate Cancer

Overview of the Solid Tumor Trial

Proportions of Patients with SREs: Protocol defined Primary Endpoint

Time To First Event: FDA preferred Primary Endpoint

PPT Slide

Heterogeneous Population

PPT Slide

Response of bone metastases to chemotherapy

PPT Slide

PPT Slide

PPT Slide

Author: CDER USER