Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced results of a randomized study comparing ZEVALIN (ibritumomab tiuxetan) injection for intravenous use plus high-dose BEAM chemotherapy vs. BEAM chemotherapy alone, published online by the journal “ CANCER ”, the Journal of the American Cancer Society ( http://www.ncbi.nlm.nih.gov/pubmed/22252613##). The paper, entitled “ A Randomized Study Comparing Yttrium-90 Ibritumomab Tiuxetan (ZEVALIN) and High-Dose BEAM Chemotherapy Versus BEAM Alone as the Conditioning Regimen Before Autologous Stem Cell Transplantation in Patients with Aggressive Lymphoma ,” presented results from a study conducted by six centers in Israel, and was authored by Avichai Shimoni, MD, Department of Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer.
Based on the exciting and promising results from this study, Spectrum’s clinical development program for ZEVALIN will be expanded to include support for a larger study using Z-BEAM for ASCT. The current clinical program includes a Phase 3 study in Diffuse Large B-Cell Lymphoma, and a trial to evaluate ZEVALIN in previously untreated follicular non-Hodgkin’s lymphoma patients.
“This study highlights a major advance for DLBCL and other patients with relapsed/refractory aggressive lymphomas since the PARMA study (1995) established ASCT as standard of care in this setting,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Unlike indolent lymphomas, which are characterized by extended remissions following treatment and overall survival in excess of 16 years, the patients in this study had relapsed aggressive lymphoma, with an abysmal prognosis even after standard ASCT of less than 4-5 years survival in most series. As a result, leading U.S. and international centers have come forward to expand on this trial and confirm the benefits of Z-BEAM in ASCT. We believe confirmatory results will lead to FDA approval and rapid adoption of ZEVALIN in this setting.”