IRVINE, Calif .- 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.
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 labeling. Importantly:
1) No additional clinical studies have been requested;
2) The additional data requested do not involve new data analyses;
3) The 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 favorable regulatory decision.
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