The first-line Indolent trial (FIT), which evaluated the use of Zevalin as first-line consolidation therapy in follicular lymphoma patients, was sponsored by Bayer Schering Pharma, which has exclusive rights to Zevalin in all countries of the world except the US. CTI has now entered into an agreement with Bayer Schering Pharma to get access to this data.
CTI expects that the data from the trial will be appropriate for the company to begin discussions with the FDA regarding the potential for a supplemental biologics license application (sBLA) for Zevalin based on Bayer’s trial results. Based on these data the European Medicines Commission recently approved Zevalin for use as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Under the terms of the agreement, CTI will make an initial payment to Bayer Schering Pharma with an additional payment upon FDA approval of an sBLA for Zevalin based on the FIT results. CTI also will pay Bayer royalties on net product sales up to a specified aggregate amount.
Cell Therapeutics has requested a meeting with the FDA to discuss expanding the label for Zevalin in the US to include consolidation following first-line treatment of follicular lymphoma based on the FIT data. If approved, this new indication is expected to increase the market for Zevalin in the US.