Spectrum Pharmaceuticals, Inc. (SPPI) 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
9/19/2012 8:43:31 AM
HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced initiation of patient enrollment in the Company’s randomized Phase 3 ZEST (Zevalin Evaluation as Sequential Therapy) trial of ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use for first-line consolidation in patients with diffuse large B-cell lymphoma (DLBCL) who achieved remission following R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). The study will assess overall survival (OS) and progression-free survival (PFS) in patients 60 years and older. Patients will consist of newly diagnosed Stage II – IV DLBCL patients with a complete response after the standard six courses of R-CHOP. They will be randomized between observation and ZEVALIN treatment.
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