Cell Therapeutics has entered into an agreement with Bayer Schering Pharma to gain access to Bayer's phase III Zevalin First-line Indolent Trial (FIT) data.
The Seattle-based CTI said it anticipates that the data from the trial will be appropriate for CTI to begin discussions with the FDA regarding the potential for a supplemental biologics license application (sBLA) for Zevalin based on Bayer's trial results.
Under the terms of the agreement, CTI will make an initial payment to Bayer Schering Pharma with an additional payment upon FDA approval of a sBLA for Zevalin based on the FIT trial results. CTI also will pay Bayer royalties on net product sales up to a specified aggregate amount.
The European Medicines Commission recently approved Zevalin for use as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established, the company said.
CTI acquired the U.S. sales and marketing rights to Zevalin in December of 2007 from Biogen Idec. Zevalin is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL.
The FIT study, which evaluated the use of Zevalin as first-line consolidation therapy in follicular lymphoma patients, was sponsored by Bayer Schering Pharma AG, who has exclusive rights to Zevalin in all countries, except the United States.