FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Oncologic
Drugs Advisory Committee
Slides Presented
The
committee will discuss New Drug Application (NDA) 21-824, Zarnestra ®
(tipifarnib) Film Coated Tablets, Tibotec Therapeutics, a division of Ortho
Biotech, LP, proposed indication for the treatment of elderly patients with
newly diagnosed poor-risk acute myeloid leukemia (AML).
Sponsor Presentation Tibotec Therapeutics, Inc.
Introduction Robert
DeLap, M.D., Ph.D.
Vice
President, Regulatory Affairs
Elderly
Richard
Stone, M.D.
Clinical
Director, Department of Adult Oncology
Dana
Farber Cancer Institute &
Associate
Professor
Clinical
Data Alain
Thibault, M.D.
Senior
Director
Oncology
Clinical Research
Benefit/Risk Alex
Zukiwski, M.D.
Vice
President
Oncology
Clinical Research
Sponsor Backup Slides
FDA Presentation
NDA 21-824, Zarnestra Qin
Ryan, M.D.
Medical
Officer, Division of Oncology Drug Products, FDA
AML
in Older Individuals Frederick
R. Appelbaum, M.D.
Director,
Clinical Research Division
Questions