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Spectrum Pharmaceuticals Initiates Phase 3 Study Of ZEVALIN® In Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL); Most Common Form Of Aggressive Non-Hodgkin’s Lymphoma

Promising results of the largest of the Phase 2 studies were presented at this year’s annual meeting of the European Hematology Association (EHA). The data demonstrated that ZEVALIN therapeutic regimen following R-CHOP treatment resulted in a 5-year overall survival rate of 84% and 5-year progression-free survival of 75% in 44 older patients (age 62-86) with stage II-IV DLBCL . Overall survival was improved approximately 15% over that observed in similar risk patients treated with R-CHOP alone, 1 justifying confirmation of this finding in a larger randomized trial.

“DLBCL consolidation therapy is a setting in which rituximab maintenance has failed to show benefit in two randomized clinical trials, whereas multiple Phase 2 studies have shown encouraging results for ZEVALIN consolidation in this setting. We feel that success of ZEVALIN in the ZEST study could lead to approval for its use in DLBCL consolidation therapy,” stated Dr. Shrotriya.

About Non-Hodgkin's Lymphoma

According to the SEER database, it estimated that more than 79,000 individuals will be diagnosed with and more than 20,000 will die of lymphoma in 2012. Of these, approximately 70,000 will be diagnosed with non-Hodgkin's lymphomas, resulting in approximately 18,940 deaths in the United States in 2012. 2 Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin's lymphoma, comprising approximately 30% of cases. 3

There are many different types of non-Hodgkin's lymphoma. These types can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing) types, and they can be formed from either B-cells or T-cells. Non-Hodgkin's lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. Prognosis and treatment depend on the stage and type of disease. DLBCL occurs primarily in older people, with a median age at diagnosis of 69.

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