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CTI Enters Into Agreement With Bayer Schering Pharma for Access to Phase III Zevalin(R) FIT Trial Data for Potential U.S. Supplemental Marketing Application
Date:6/17/2008

trated that when used as a first-line consolidation therapy for patients with follicular lymphoma, Zevalin significantly improved the median progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001).

The primary investigators of the study concluded that Zevalin consolidation of first remission in advanced stage follicular lymphoma is highly effective, resulting in a total complete response (CR + CRu) rate of 87 percent and prolongation of median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with Zevalin's use in approved indications. Zevalin-treated patients had reversible Grade 3 or 4 hematologic side effects including neutropenia in 67 percent, thrombocytopenia in 61 percent, and anemia in 3 percent. Nonhematologic toxicities were 23.5% Grade 3, and Grade 3/4 infection was 7.9%.

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate nonhematologic toxicities were 23.5% Grade 3, and Grade 3/4 infection was 7.9%. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regi
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SOURCE Cell Therapeutics, Inc.
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