Oncologic
Drugs Advisory Committee
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 |
Pamela Haylock, RN Member, ODAC |
Introduction – Accelerated
Approval Process |
Ramzi Dagher, M.D., Medical Officer Division of Oncology Drug Products, FDA |
EMEA Presentation |
Francesco Pignatti, M.D. Scientific Administrator The European Medicines Agency |
Sponsor Presentations
and Discussion |
|
Sponsor Presentation DOXIL – Treatment of AIDS-related Kaposi’s Sarcoma |
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 |
Ligand Pharmaceuticals, Inc. Andres
Negro-Vilar, M.D., Ph.D. Senior
Vice President, Research & Development, Chief
Scientific Officer |
Sponsor Presentation Mylotarg ® (gemtuzumab ozogomicin) |
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 |
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 |
Genzyme Corporation Cynthia
Sirard, M.D. Medical
Director, Clinical Research |
Open Public Hearing Speakers |
|
|
Steve Walker Chief AdvisorAbigail |
Questions Presented After Each Sponsor
Presentation |
|
Accelerated Approval: Questions to the Committee
|
|