Food and Drug Administration
Oncologic Drugs Advisory Committee
September 11, 2001
BLA 125019, Zevalin™ (ibritumomab tiuxetan), IDEC
Pharmaceuticals Corporation
- indicated for the treatment of patients with relapsed or refractory low
grade, follicular or CD20+ transformed B cell Non-Hodgkins lymphoma (NHL) and
rituximab refractory follicular NHL
IDEC Pharmaceuticals Corporation
Ibritumomab Tiuxetan (Zevalin™) Radioimmunotherapy of Non-Hodgkin’s Lymphoma
Disclaimer
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.
Sponsor Presentation pdf
FDA Presentation
Review of Biologica License Application for IDEC Pharamceutical Zevalin™ Kit (BLA# 125019) pdf doc