Oncologic Drugs Advisory Committee

November 8, 2005

Slides Presented at Meeting

The Oncologic Drugs Advisory Committee will discuss new drug applications approved under 21 CFR 314.500 and Part 601.40 (Subpart H and Subpart E, respectively, accelerated approval regulations) in an open session on to: (1) Review the status of phase IV clinical studies; (2) identify difficulties associated with completion of phase IV commitments; and (3) provide advice to sponsors to assist in the planning and execution of post-marketing commitments of newly approved drugs.  

Report to Committee on Pediatric

Oncology Subcommittee Meeting

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Pamela Haylock, RN

Member, ODAC

Introduction – Accelerated Approval Process

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Ramzi Dagher, M.D., Medical Officer

Division of Oncology Drug Products, FDA


EMEA Presentation

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Francesco Pignatti, M.D.

Scientific Administrator

The European Medicines Agency

Sponsor Presentations and Discussion


Sponsor Presentation

DOXIL – Treatment of AIDS-related Kaposi’s Sarcoma

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Johnson & Johnson, Ltd.

Wayne Rackoff, M.D.

Clinical Leader for DOXIL


Backup Slides Presented by Johnson & Johnson




Sponsor Presentation

Ontak ® (denileukin diftitox) Post Approval Commitments

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Ligand Pharmaceuticals, Inc.

Andres Negro-Vilar, M.D., Ph.D.

Senior Vice President, Research & Development,

Chief Scientific Officer


Sponsor Presentation

Mylotarg ® (gemtuzumab ozogomicin)

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Wyeth Pharmaceuticals, Inc.

Lee Allen, M.D., Ph.D.

Vice President, Medical Research


Sponsor Presentation

Depocyt: Enrollment Completed



Skyepharma, Inc.

Gordon Schooley, Ph.D.

Chief Scientific Officer


Sponsor Presentation

Celebrex: Therapy of Familial Adenomatous

Polyposis (FAP), subpart H approval

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Pfizer, Inc.

Craig Eagle, M.D.

Medical Director/Team Leader – Celebrex

Worldwide Oncology, Worldwide Medical


Sponsor Presentation

Campath (aletuzumab): Status of Phase IV

Postmarketing Commitments

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Genzyme Corporation

Cynthia Sirard, M.D.

Medical Director, Clinical Research


Open Public Hearing Speakers

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Steve Walker

Chief AdvisorAbigail Alliance Organization



Questions Presented After Each Sponsor Presentation

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Accelerated Approval:

Questions to the Committee

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