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Lymphoma

CTI Enters Into Agreement With Bayer Schering Pharma for Access to Phase III Zevalin(R) FIT Trial Data for Potential U.S. Supplemental Marketing Application

Published in Medical Letter on the CDC and FDA, July 6th, 2008

Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced 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...

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