Expanded indication approved for Zevalin

The 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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