Landmark Study Demonstrates Potential of Radioimmunotherapy for Treatment of Indolent B-Cell Non-Hodgkin'...( Zevalin(R) First-Line Indolent (FI...),Health

Zevalin(R) First-Line Indolent (FIT) Phase III Clinical Trial results

published in Journal of Clinical Oncology

SEATTLE, Oct. 16 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the Journal of Clinical Oncology has published the results of the First-line Indolent Trial (FIT) demonstrating that use of Zevalin(R)([90Y]-ibritumomab tiuxetan) in consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma provided important patient benefits including a significant improvement in progression free survival. A companion editorial discussed the growing evidence for the efficacy of radioimmunotherapy (RIT) in B-cell lymphomas. Cell Therapeutics has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for use of Zevalin in first-line consolidation therapy based on the FIT data.

Oliver W. Press, M.D., Ph.D., Member of the Fred Hutchinson Cancer Research Center and Professor at the University of Washington, commented in his editorial that the studies "confirm and extend prior data demonstrating the tremendous potential of RIT in the treatment of B-cell NHL at diagnosis and after relapse at both conventional and myeloablative doses. Despite the overwhelming body of evidence, however, RIT remains underused in the United States and other countries. The reasons for this underuse have been widely debated but seem to be related, at least partially, to logistic issues involved in the transfer of care from the hematologist/oncologist to the nuclear medicine physician, concerns about inadequate reimbursement by Medicare for RIT, and exaggerated emphasis on delayed effects such as marrow damage and secondary malignancies. It is hoped that studies such as those in this issue would encourage wider appreciation and use of RIT."

"We couldn't agree more with Dr. Press' comments about
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