FDA requested clinical data from an already conducted trial to support Spectrum Pharmaceuticals’ sBLA for Zevalin. The company is seeking to expand the drug’s use into the first-line consolidation setting for non-Hodgkin’s Lymphoma (NHL) patients.
Zevalin is currently approved 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 agency’s complete response letter suggests that this additional information from an evaluation called the FIT study will verify a subset of the data that is currently under review to support the proposed labeling. FDA has not asked the company to conduct further clinical studies or new data analyses. Spectrum plans to formally respond to all requests by July 8.
Spectrum is confident that the submission of this data will satisfy the requirements of the complete response letter and expects a favorable regulatory decision. The FIT study showed progression-free survival of 67 months compared to 30.8 months for those in the control group. Also, the trial provided evidence that Zevalin consolidation does not adversely affect the use of second-line treatments like stem cell transplants, according to Spectrum Pharmaceuticals.