FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

Slides Presented

May 5, 2005:

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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).

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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

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Sponsor Backup Slides

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FDA Presentation

NDA 21-824, Zarnestra Qin Ryan, M.D.

Medical Officer, Division of Oncology Drug Products, FDA

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AML in Older Individuals Frederick R. Appelbaum, M.D.

Director, Clinical Research Division

Fred Hutchinson Cancer Research Center

Seattle, Washington

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Questions

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