Access to data may provide potential for label expansion in the U.S.
SEATTLE, June 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced today an agreement with Bayer Schering Pharma to gain access to Bayer's phase III Zevalin(R) ([90Y]-ibritumomab tiuxetan) First-line Indolent Trial, FIT data. CTI expects that the data from the trial will be appropriate for CTI to begin discussions with the U.S. Food and Drug Administration (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. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
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. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival. Studies to determine whether the Zevalin therapeutic regimen confers an effect on progression-free survival are ongoing.
The FIT study, which evaluated the use of Zevalin as first-line
consolidation therapy in follicular lymphoma patients, was sponsored by
|SOURCE Cell Therapeutics, Inc.|
Copyright©2008 PR Newswire.
All rights reserved