Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee


Slides Presented


May 5, 2005:

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

Harvard Medical School


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

Fred Hutchinson Cancer Research Center

Seattle, Washington