Food and Drug Administration

Oncologic Drugs Advisory Committee

December 17, 2002

Iodine I 131 Tositumomab

Briefing Information


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Iodine I 131 Tositumomab (Tositumomab and Iodine I 131 Tositumomab), Corixa Corp. (PDF)

Product: Inodine I 131 tositumomab (PDF)

FDA Table of Contents (PDF)

Administrative History, FDA (HTM) (PDF) (Word)

Executive Summary, FDA (HTM) (PDF) (Word)

Background Information on Non-Hodgkin's Lymphoma, FDA (HTM) (PDF) (Word)

Description of the Product, FDA (HTM) (PDF) (Word)

Clinical Studies Overview, FDA (HTM) (PDF) (Word)

Study CP-97-012, FDA (HTM) (PDF) (Word)

Supportive Phase 1 and Phase 2 Studies, FDA (HTM) (PDF) (Word)

Transformed Low-Grade Non-Hodgkin's Lymphoma, FDA (HTM) (PDF) (Word)

Long Term Responders, FDA (HTM) (PDF) (Word)

Integrated Summary of Safety, FDa (HTM) (PDF) (Word)

Biodistribution and Dosimetry, FDA (HTM) (PDF) (Word)

Appendix 1: Communication With Sponsor, FDA (HTM) (PDF) (Word)

Appendix 2: Bioresearch Monitoring Inspection Results, FDA (HTM) (PDF) (Word)

Financial Disclosure, FDA (PDF)

ERRATA for the FDA Review of BL STN 125011/0 Bexxar® (HTM) (PDF) (Word)