September 08, 2009
Expanded indication approved for ZevalinThe FDA has approved an expanded label for Zevalin (ibritumomab tiuxetan, from Spectrum) to include the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma (NHL) who achieve a partial or complete response to first-line chemotherapy. This approval was based on data from the FIT (First-line Indolent Therapy) Study, a Phase 3, multicenter, randomized, open-label study evaluating Zevalin in 414 CD20-positive follicular NHL patients who had achieved a partial response or a complete response after receiving a first-line chemotherapy regimen (chlorambucil, fludarabine, fludarabine-containing regimen, CVP/COP, CHOP, CHOP-like, or rituximab-containing chemotherapy). At 3.5 years of follow-up, the FIT trial demonstrated that when used as part of first-line chemotherapy for patients with follicular NHL, Zevalin significantly improved the median progression-free survival time from 18 months (control group) to 38 months (Zevalin group) (p<0.0001).
Zevalin, a CD20 directed radiotherapeutic antibody, is already indicated for treatment of B-cell non-Hodgkin's lymphoma (relapsed or refractory, low grade, follicular, transformed, or rituximab-refractory).
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