Landmark Study Demonstrates Potential of Radioimmunotherapy for Treatment of Indolent B-Cell Non-Hodgkin'...(the importanceof these results for patie...),Health

Date:10/15/2008

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<0.0001). This advantage was observed regardless of whether patients were in partial remission (29.3 v 6.2 months p<0.0001 without Zevalin) or complete remission (53.9 v 29.5 months p=0.0154). Furthermore, Zevalin consolidation converted 77 percent of patients who had achieved only a partial remission (PR) after induction therapy to complete remission / complete remission unconfirmed (CR/CRu). Nearly all subgroups appeared to benefit regardless of prognostic score.

The primary investigators of the study concluded that Zevalin c
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SOURCE Cell Therapeutics, Inc. Copyright©2008 PR Newswire. All rights reserved

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