Food and Drug Administration

Oncologic Drugs Advisory Committee

May 4, 2004

Briefing Information

Aranesp® (Darbepoetin Alfa) Safety, Amgen, Inc.(HTM) (PDF) (Word)

Safety of Erythropoietin Receptor Agonists (ERAs) in Patients With Cancer, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (HTM) (PDF) (Word)

Neorecormon® (Epoetin Beta), Hoffman-La Roche, Ltd (PDF)

Safety Concerns Associated With Aramesp (Darbepoetin Alfa) Amgen, Inc. and Procrit (Epoetin Alfa) Ortho Biotech, L.P., for the Treatment of Anemia Associated With Cancer Chemotherapy, FDA (HTM) (PDF) (Word)

Errata for the FDA Briefing Document (HTM) (PDF) (Word)

Table of Contents (HTM) (PDF) (Word)

Memorandum Outlining the Purpose of the Afternoon Session and Describing the Content of the Briefing Information (HTM) (PDF) (Word)

Colorectal Cancer Endpoints Workshop November 12, 2003 (HTM) (PDF) (Word)

Bibliography (HTM) (PDF) (Word)