Spectrum Pharmaceuticals Gets FDA Response For Zevalin

Spectrum Pharmaceuticals has received a complete response letter from the US Food and Drug Administration (FDA). The response was 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.

Following the receipt of the response letter, Spectrum has to submit data from the FIT study to FDA to validate Subset Of sBLA Package.

At present, ZEVALIN is 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.