Oncologic Drugs Advisory Committee Meeting

June 2, 2006

 

 

Slides Presented at Meeting

Sprycel (Dasatib)

NDA 21-986

Welcome and Introductory Comments

 

Richard Pazdur, M.D., Director

Office of Oncology Drug Products, OODP

Sponsor Presentation (ppt) (htm)
Backup Slides (ppt) (htm)

Introduction

 

Problem Statement

 

Clinical Program

 

 

Clinical Perspective & Benefit and Risk

Assessment

 

Conclusion

Bristol-Myers Squibb Company

 

Donna Morgan Murray, Ph.D.

 

Neil Shah, M.D., UCLA Medical Center

 

Claude Nicaise, M.D., VP, Global Development

 

Hagop Kantarjian, M.D.

MD Anderson Cancer Center

 

Donna Morgan Murray, Ph.D.

FDA Presentation (ppt) (htm)

Efficacy

 

 

Safety

NDA 21-986

 

Edvardas Kaminskas, M.D.,

DDOP, OODP

 

Vicki Goodman, M.D.

DDOP, OODP

Open Pulic Hearing Speakers (ppt) (htm)

 

 

Questions for the Committee (ppt) (htm)