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


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

Errata   pdf   htm

FDA Presentation

Review of Biologica License Application for IDEC Pharamceutical Zevalin™ Kit (BLA# 125019)   pdf  doc