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  • imho_dyodd imho_dyodd Dec 1, 2012 4:48 PM Flag

    Zevalin administration licensing requirements and it's impact to sales

    Zevalin (ibritumomab tiuxetan) is a murine anti-CD20 monoclonal antibody covalently bound the chelator tiuxetan which can securely chelate 90Y. We performed a randomized controlled trial comparing Zevalin radioimmunotherapy (RIT) with rituximab immunotherapy in 143 pts with relapsed or refractory low-grade, follicular, or CD20+ transformed B-cell NHL. The primary efficacy variable was ORR. The Zevalin regimen consists of Day 0 and D7 rituximab 250 mg/m[sup2] followed on Day 7 with 0.4 mCi/kg 90Y Zevalin. Control arm pts received 4 weekly doses of 375mg/m[sup2] rituximab. Baseline characteristics were well-balanced. There was no statistical difference between the Zevalin and rituximab groups in median age (60 vs. 57 yrs); histology (follicular 75% vs 83%); median prior therapy regimens (2); bone-marrow involvement (43% vs. 36%); splenomegaly (10% vs. 4%); bulky disease [greater than or equal to] 5 cm (45% vs. 44%), [greater than or equal to] 7 cm (21% vs. 26%), [greater than or equal to] 10 cm (8% vs. 7%); chemotherapy resistance (56% vs 64%); IPI risk group; performance status; or extranodal disease. All pts had acceptable biodistribution and dosimetry estimated radiation absorbed doses to normal organs. Zevalin adverse events were primarily hematologic. Six percent developed Gr 4 thrombocytopenia, 32% Gr 4 neutropenia, and 8% required hospitalization for infection. HAMA incidence was

6.86+0.02(+0.29%)3:37 PMEDT