ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING

ONCOLOGIC DRUGS ADVISORY COMMITTEE

December 14, 2000

SLIDES

BLA 99-0786 Campath (alemtuzumab) - indicated for the treatment of patients with chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy

Millenium and ILEX Partners LP

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Overview of CLL: Need for New Therapeutic Options; presentation of Clinical Data, Micahel J Keating, MB, BS, MD, Anderson Cancer Center, Lee R Brettman, MD, Millenium Pharmaceuticals ppt html

FDA Presentation, Genevieve Schechter, MD ppt html

Single Patient Use of Non-approved Oncology Drugs and Biologics

Introduction, Grant Williams, MD, FDA ppt html

Perspective from Industry

Robert Spiegel, MD, Schering-Plough Research Institute ppt html

Gerard T Kennealey, MD, AstraZeneca Pharmaceuticals ppt html