NEW YORK -- September 4, 2009 -- The US Food and Drug Administration (FDA) has approved an expanded label for ibritumomab tiuxetan (Zevalin) for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy.
The approval of the new indication was based on data from the multicentre, randomised, open-label, phase 3 First-line Indolent Therapy (FIT) study, which evaluated the safety and efficacy of ibritumomab tiuxetan in 414 patients with CD20-positive follicular NHL who had achieved a partial response or a complete response after receiving a first-line chemotherapy regimen.
Patients were treated with 1 of the following first-line chemotherapy regimens: 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, ibritumomab tiuxetan significantly improved the median progression-free survival time from 18 months to 38 months (P < .0001).
The safety profile of ibritumomab tiuxetan was consistent with previous clinical studies, with haematologic toxicity as the most common adverse reaction in the FIT study.
SOURCE: Spectrum Pharmaceuticals
