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news.Spectrum has reported results from a randomised study comparing ZEVALIN (ibritumomab tiuxetan) injection for intravenous use plus high-dose BEAM chemotherapy vs. BEAM chemotherapy alone.
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The randomised study has evaluated the safety and efficacy of standard-dose ZEVALIN 14 days prior to ASCT, followed by high-dose BEAM chemotherapy (Z-BEAM) and ASCT in refractory/relapsed aggressive lymphoma.
Two year overall survival rate was 91% for Z-BEAM vs. 62% for BEAM Alone (p= 0.05).
The standard-dose ibritumomab tiuxetan combined with BEAM high-dose chemotherapy is safe and effective than BEAM alone as conditioning regimen for ASCT in the era of rituximab-containing chemotherapy regimens.
The company will expand clinical development program for ZEVALIN to include support for a larger study using Z-BEAM for ASCT.
Spectrum chairman and CEO Rajesh Shrotriya said that they believe confirmatory results will lead to FDA approval and rapid adoption of ZEVALIN in this setting.