Spectrum Pharmaceuticals, Inc. Receives Complete Response Letter from FDA for Zevalin

IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage biotechnology company with a focus in oncology, today announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental Biologics License Application (sBLA) for ZEVALIN® (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin’s Lymphoma (NHL) patients. The Prescription Drug User Fee Act (PDUFA) Action Date for the ZEVALIN sBLA in the first-line consolidation setting was July 2, 2009. ZEVALIN is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.