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Zevalin Consolidation in Patients With Complete Remission After Induction Therapy Results in Durable Remission of More Than 67 Months
Date:12/8/2008

nted an additional 1-year follow-up (median follow-up of 42 months) of the FIT study that included 409 patients who achieved a CR/CRu or PR after induction therapy. Patients that achieved a CR after induction therapy achieved a median PFS of >67 months for the Zevalin arm compared to 30.8 in the control arm (HR 0.61[95% CI .41-.91]; p = 0.015). Patients that achieved a PR after induction therapy achieved a median PFS of 29.6 months for the Zevalin arm compared to 6.7 months in the control arm (HR 0.36[95% CI .25-.51]; p < 0.001).

Subsequent therapy with various modalities including chemotherapy, radiotherapy, immunotherapy, Zevalin and stem cell transplation (ASCT) was given to 63 patients in the Zevalin arm and 108 patients in the control arm, who achieved an overall response rate of 81% and 73%, respectively. The results demonstrate that administration of Zevalin as consolidation therapy does not preclude the use of effective second line therapies.

No previously unreported toxicities were noted and there was no increase in the incidence of secondary malignancies to date in patients treated with Zevalin as compared to control patients.

CTI has submitted a supplemental Biologics License Application (sBLA) to the FDA based on the FIT data obtained through an agreement with Bayer Schering Pharma AG, Germany. The FDA has accepted the application for review and granted a priority review status with a Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 for a decision on the application.

About First-Line Consolidation Therapy

Consolidation therapy is a treatment given after initial induction therapy and is aimed at improving the quality of the patient response by further diminishing the number of cancer cells with the goal of extending the response duration.

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer ther
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SOURCE Cell Therapeutics, Inc.
Copyright©2008 PR Newswire.
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