FDA approves Zevalins expanded label for NHL treatment

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Spectrum Pharmaceuticals, a biotechnology oncology company, has received FDA approval for Zevalin (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, for an expanded label 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 expanded indication supplements the 2002 FDA approval of Zevalin as treatment for patients with relapsed or refractory, low-grade or follicular B-cell NHL, according to the Irvine, Calif.-based company.

The approval of the new indication was based on data from the FIT study (First-line Indolent Therapy), a multicenter, randomized, open-label phase 3 study to evaluate the safety and efficacy of Zevalin 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.