Landmark Study Demonstrates Potential Of Radioimmunotherapy For Treatment Of Indolent B-cell Non-hodgkin's Lymphoma

October 23, 2008

Cell Therapeutics, Inc. (CTI) announced 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 the importance of these results for patients with newly diagnosed follicular NHL as well as his views as to why this important therapeutic option is underutilized by physicians," noted James Bianco, M.D., CEO of Cell Therapeutics. "We have been working with CMS in making reimbursement for RIT similar as any biologic agent, and with the FDA on reviewing the FIT results for a potential indication as consolidation therapy following first-line therapy in newly diagnosed patients as well as removing the need for the pre-treatment nuclear medicine scan on the basis of studies such as FIT and accumulated safety data. We believe these steps will allow office based hematologist/oncologists the ability to offer RIT with Zevalin to their patients eliminating many of the current concerns that have limited patient access to this important treatment option."

The multinational, randomized phase III First-line Indolent Trial (FIT) evaluated the benefit and safety of a single infusion of Zevalin in 414 patients with CD20-positive follicular non-Hodgkin's lymphoma who had achieved a partial response or a complete response after receiving a variety of first-line chemotherapy regimens. The FIT trial demonstrated that when used as a first-line consolidation therapy for patients with follicular non-Hodgkin's lymphoma, Zevalin significantly improved the median progression-free survival time from 13.3 months (control arm) to 36.5 months (Zevalin arm) (p

http://www.cancercompass.com/