Idec Zevalin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's Oncologic Drugs Advisory Committee will review the non-Hodgkin's lymphoma therapy ibritumomab tiuxetan Sept. 11. As a condition of approval, FDA has requested a Phase IV trial to study use of the antibody in patients previously exposed to murine-based anti-cancer therapies. Zevalin received a "complete review" letter May 3 (Pharmaceutical Approvals Monthly, June 2001, p. 16)