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news.Spectrum Pharmaceuticals has received the US Food and Drug Administration (FDA) acceptance for the review of the Prior Approval Supplement containing data providing for the removal of the Indium-111 Zevalin (ibritumomab tiuxetan) pre-treatment imaging evaluation, more commonly referred to as the 'bioscan' requirement.
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Zevalin is a CD20-directed radiotherapeutic antibody.
Zevalin injection for intravenous use is indicated 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.
Zevalin is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma.
The Zevalin therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy.