ONCOLOGIC DRUGS ADVISORY COMMITTEE

March 17, 2000

Briefing Information

Gemtuzumab Zogamicin

FDA Medical Officer Review, Gemtuzumab Zogamicin, Recombinant Humanized Anti-CD33 Monoclonal Antibody (HP67.6 Antibody)-Calicheamicin Drug Conjugate in Relapsed Acute Myelogenous Leukemis, NDA 21-174

Statistical Review and Evaluation - Summary Statement, Peter Bross, MD, Rajeshwari Sridhara, PhD

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

Summary for Presentation to the FDA's Oncologic Division Advisory Committee, Wyeth-Ayerst Research