Landmark Study Demonstrates Potential Of Radioimmunotherapy For Treatment Of Indolent B-Cell Non-Hodgkin's Lymphoma

Cell Therapeutics, Inc.
(CTI) (Nasdaq and MTA: CTIC) 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) (pBuy Elimite Without Prescription