Spectrum Pharmaceuticals, Inc, a commercial stage biotechnology company with a focus on oncology, announced that the US Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the company's supplement to the biologics license application for Zevalin (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009.
Zevalin is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin's Lymphoma.
Zevalin (ibritumomab tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL.
Spectrum Pharma is a commercial-stage biotechnology company with a focus in oncology.