Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a focus in oncology, has received a Complete Response letter from the US 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.

The FDA requested the company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labelling. No additional clinical studies have been requested; additional data requested do not involve new data analyses; company plans to formally respond to the FDA's requests by this Wednesday, July 8, 2009.

Spectrum is confident that the data it will submit will satisfy the requirements of the Complete Response letter, and, at this time, continues to expect a favourable regulatory decision.

Spectrum Pharma is a commercial-stage biotechnology company with a focus in oncology. The company's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy.