Spectrum Pharmaceuticals has submitted a formal response to the Complete Response Letter it received from the FDA. It 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.
ZEVALIN is currently FDA approved and marketed by Spectrum. It is intended for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL.
Rajesh Shrotriya, President, Chairman, and CEO of Spectrum Pharmaceuticals, said: “We believe that the data we submitted will satisfy the requirements of the FDA. We continue to expect a favorable regulatory decision.”
Earlier, 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.