Food and Drug Administration

Center for Drug Evaluation and Research


Oncologic Drugs Advisory Committee

Meeting Agenda

March 12-13, 2003

                                                                                                                                        Versailles Ballroom

74th  Meeting                                                                                               Holiday Inn

                                                                                                                                            Bethesda, MD


March 12, 2003


8:00                  Call to Order and Opening Remarks                                      Donna Przepiorka, M.D., Ph.D.

                                                                                                                Chair, ODAC

                            Introduction of Committee


                       Conflict of Interest (COI) Statement                                      Johanna Clifford, M.S.,RN, BSN



8:15                  Open Public Hearing



8:45    Introduction – Accelerated Approval Process                        Richard Pazdur, M.D., Director

                                                                                                   Ramzi Dagher, M.D., Medical Officer

                                                                                                  Division of Oncology Drug Products 

                                                                                                  Center for Drug Evaluation & Research                       Division of Oncologic Drugs


9:15   Sponsor Presentation                                                           Steven Hamburger, Ph.D.

                                                                                                  Johnson & Johnson Pharmaceutical

                                                                                                  Research & Development, LLC            

                          NDA 50-718 Doxil (doxorubicin hydrochloride liposome)

Indication: Treatment of Kaposi’s sarcoma in AIDS patients with disease that

has progressed on prior combination therapy or in patients who are intolerant

to such therapy.


9:30                   FDA Comments & ODAC Discussion                                  Bruce Redman, D.O.

                                                                                                                 ODAC Discussant


10:15                Break


                        COI Statement & Introduction of New Participants                 Johanna Clifford, M.S., RN, BSN


10:30                Sponsor Presentation                                                           Steven Hamburger, Ph.D.

                                                                                                                 Johnson & Johnson Pharmaceutical

                                                                                                                 Research & Development, LLC

                        NDA 50-718/S-006 Doxil (doxorubicin hydrochloride liposome)                                                                                    

                        Indication: Treatment of metastatic ovarian cancer in patients with disease that

                                is refractory to both paclitaxel and platinum-based chemotherapy regimens.                                                                                                                                                                             


10:45                FDA Comments & ODAC Discussion                                   Otis Brawley, M.D.

                                                                                                                 ODAC Discussant


11:30                Lunch


12:30                Open Public Hearing


                        COI Statement & Introduction of New Participants                 Johanna Clifford, M.S., RN, BSN




1:00                  Sponsor Presentation                                                           James L’Italien, M.D. &

                                                                                                                 Gordon Bray, M.D.

                                                                                                                 Ligand Pharmaceuticals, Inc.

                        BLA 97-1325/STN 103767 Ontak (denileukin diftitox)      

                        Indication: Treatment of persistent or recurrent cutaneous T-Cell lymphoma in

                                patients whose maligant cells express the CD25 component of the IL-2 receptor.


1:15                  FDA Comments & ODAC Discussion                                   Bruce Cheson, M.D.

                                                                                                                 ODAC Discussant


2:00                  Break


                        COI Statement & Introduction of New Participants                Johanna Clifford, M.S., RN, BSN         


2:15                  Sponsor Presentation                                                           James Pluda, M.D.

                                                                                                                 MedImmune Oncology, Inc.

                        NDA 20-221/S-002 Ethyol (amifostine)                                  

                        Indication: Reduction in cumulative renal toxicity associated with repeated

                             administration of cisplatin in patients with advanced non-small cell lung cancer.                                                                                                                                                                       


2:30                  FDA Comments & ODAC Discussion                                   Douglas Blayney, M.D.

                                                                                                                 ODAC Discussant


3:15                  Estimated Time of Adjournment                                    



March 13, 2003                                                                                              


8:00                  Call to Order and Opening Remarks                                     Donna Przepiorka, M.D., Ph.D.

                                                                                                                Chair, ODAC

                        Introduction of Committee


                        Conflict of Interest Statement                                             Johanna Clifford, M.S., RN, BSN

                                                                                                                Executive Secretary, ODAC

8:15                   Open Public Hearing


8:45                  Sponsor Presentation                                                          Matthew L. Sherman, M.D.

                                                                                                                                             Wyeth-Ayerst Laboratories, Inc.

                                NDA 21-174   Mylotarg (gemtuzumab ozogamicin)

                                Indication:  Treatment of CD33 positive acute myeloid leukemia patients

                                 in first relapse who are 60 years of age or older and  who are not considered candidates

                                for cytotoxic chemotherapy.



9:00                  FDA Comments & ODAC Discussion                                   Donna Przepiorka, M.D., Ph.D

                                                                                                                ODAC Chair

9:45                  Break


                        COI Statement & Introduction of New Participants                Johanna Clifford, M.S., RN, BSN


10:00                Sponsor Presentation                                                          Stephen Howell, M.D.

                                                                                                                Skyepharma, Inc.      

                        NDA 21-041 Depocyt (cytarabine liposomal injection)

                                Indication: Intrathecal treatment of lymphomatous meningitis


10:15                FDA Comments & ODAC Discussion                                    Gregory Reaman, M.D.

                                                                                                                 ODAC Discussant

11:00                Lunch


12:00                Open Public Hearing


                        COI Statement & Introduction of New Participants                  Johanna Clifford, M.S., RN, BSN


12:30                Sponsor Presentation                                                            Daniel Vlock, M.D.  

                                                                                                                  Pharmacia Corporation

                        NDA 21-156 Celebrex (celecoxib)

                                Indication: Reduction in number of adenomatous colorectal polyps in familial

                                 adenomatous polyposis (FAP) patients.


12:45                FDA Comments & ODAC Discussion                                    David Kelsen, M.D.

                                                                                                                  ODAC Discussant

1:30                  Break


                        COI Statement and Introduction of New Participants               Johanna Clifford, M.S., RN, BSN


1:45                  Sponsor Presentation                                                            Craig Tendler, M.D.

                                                                                                                  Schering-Plough Corporation

                        NDA 21-029 Temodar (temozolomide)

                                Indication: Treatment of refractory anaplastic astrocytoma


2:00                  FDA Comments & ODAC Discussion                                    Sarah Taylor, M.D.

                                                                                                                  ODAC Discussant

2:45                  Introduction of Questions and Committee Discussion


4:00                  Estimated Time of Adjournment  





Patient Representative (Voting):                                                      


                        Musa Mayer - New York, NY                                   


Consultant (Voting):


                        Thomas Fleming, Ph.D.

                        Professor and Chair

                        Department of Biostatistics

                        University of Washington

                        Box 357232

                        Seattle, WA 98195


Acting Industry Representative (Non-Voting):


                        George Ohye

                        3 Heritage Hills Court

                        Skillman, NJ 08558-2340