FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee
AGENDA
Introduction
of Committee Chair,
ODAC
Conflict
of Interest Statement Johanna
Clifford, M.S., RN,
Executive
Secretary, ODAC
The committee
will discuss New Drug Application (NDA) 21-649, Genasense™ (oblimersen sodium)
Genta, Incorporated, proposed
indication for use in combination with DTIC dome ® (dacarbazine), Bayer
Pharmaceuticals Corporation, proposed
for the treatment of patients with advanced malignant melanoma.
Division of Oncology Drug
Products, FDA
Introduction Loretta
M. Itri, M.D.
Melanoma Overview John
M. Kirkwood, M.D.
Study GM301 Loretta
M. Itri, M.D.
Clinical Benefit Summary Frank Haluska, M.D.,
Ph. D.
Division of Oncology Drug
Products, FDA
Page 2
The committee will discuss NDA 21-661, RSR 13 Injection (efaproxiral sodium) Allos
Therapeutics Inc., proposed
indication for use as an adjunct to whole brain radiation therapy in the
treatment of brain metastases from primary breast cancer.
Introduction Pablo J. Cagnoni, M.D., Vice
President, Clinical Therapeutics
Brain Metastases John H. Suh, M.D., Clinical
Director, Radiation Oncology
The Science of RSR: Drug Design
Rational, Brian D. Kavanaugh, M.D., M.P.H., Dept. of Radiation
Oncology,
Mechanism of Action, and
Initial Translation
into the Clinic
Clinical Efficacy Pablo
J. Cagnoni, M.D.
Safety
Profile of Efapoxiral (RSR13)
Conclusions Dr.
Paul Bunn, M.D. Paul Bunn, M.D.
Professor
and Director
University
of
Division
of Oncology Drug Products, FDA
Biostatistics and Information
Systems
FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee
AGENDA
Introduction
of Committee
Conflict
of Interest Statement Johanna Clifford, M.S., RN, Executive Secretary, ODAC
The
committee will discuss safety
concerns associated with Aranesp (darbepoetin alfa) Amgen, Inc., and Procrit
(epoetin alfa) Johnson & Johnson, Ltd., both of
which are indicated for the treatment of anemia associated with cancer chemotherapy.
Division of Therapeutic
Biological Oncology Products, FDA
Sponsor Presentations
Introduction Robert DeLap, M.D., Ph.D., Vice
President
Global
Regulatory Affairs
Evaluation
of Studies Peter
Bowers, M.D., Senior Director, Clinical Team Leader
EPO, Drug Development
Future Clinical Data Martine
George, M.D. Vice President, Hematology & Oncology
Clinical
Research and Global Development
Introduction Dawn Viveash, M.D., Vice
President, Regulatory Affairs & Safety
Aranesp Properties, Pre-Clinical Glenn Begley, M.D., Ph.D., Vice President, Hematology
Research
Observations & EPO Receptor Biology
Aranesp Clinical Observations
& David Parkinson, M.D. Vice
President, Oncology Clinical Dev.
Pharmacovigilance Program Conclusions
Division of Therapeutic
Biological Oncology Products, FDA
Page 2
Conflict
of Interest Statement Johanna Clifford, M.S., RN, Executive Secretary, ODAC
The
Committee will discuss colo-rectal cancer endpoints as a follow up to the
November 2003 FDA Workshop.
Division
of Oncology Drug Products, FDA
FDA Approvals in Colorectal cancer Division of Oncology Drug Products, FDA
Endpoints Workshop Division of Medical Oncology
Overall Survival (OS) as a Primary Endpoint
for Adjuvant