Food and Drug Administration

Oncologic Drugs Advisory Committee

May4, 2004

Slides

Epoetin beta in the Treatment of Anemia in Cancer Patients, Dr. Marty Huber, MD, Roche Pharmaceuticals (HTM) (PPT)

Update on the Safety of Erthropoietin Products in Patients With Cancer, Dr. Robert DeLap, MD, PhD, Johnson & Johnson (HTM) (PPT)

Update on the Safety of Erthropoietin Products in Patients With Cancer, Dr. Peter Bowers, MD, John & Johnson (HTM) (PPT)

Update on the Safety of Erthropoietin Products in Patients With Cancer, Dr. Martine George, MD, Johnson & Johnson (HTM) (PPT)

Amgen Presentation: Aranesp® (darbepoetin alfa) Therapy for Oncology Patients (HTM) (PPT)

Evolving Safety Issues Associated With Erythropoietin Products, Dr. Harvey Luksenburg, MD, FDA (HTM) (PPT)

Regulatory Background and Past FDA Approvals in Colorectal Cancer, Dr. Amna Ibrahim, MD, DODP, FDA (HTM) (PPT)

Synopsis of FDA Colorectal Cancer Endpoints Workshop, Dr. Michael O'Connell, MD, Allegheny Cancer Center (HTM) (PPT)

Disease Free Survival vs Overall Survival as an Endpoint for Adjuvant Colon Cancer Studies: Data From Randomized Trials, Dr. Daniel Sargent, PhD, Mayo Clinic (HTM) (PPT)

Open Public Hearing

Progression as an Endpoint in CRC, Kevin Carroll, BSc, MSc, FRSS, AstraZeneca Pharmaceuticals (HTM) (PPT)