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ASCO News In Brief: Coulter Pharmaceuticals 131-I-anti-B1

Executive Summary

Coulter Pharmaceuticals 131-I-anti-B1: Anti-CD20 monoclonal antibody non-myeloablative radioimmunotherapy shows 72% complete or partial remission rate in B-cell lymphoma patients who failed prior chemotherapy, Mark Kaminiski, MD, University of Michigan Medical Center, reports. The 47-patient Phase I/II study treated patients with an initial tracer dose of 131-I-anti-B1 (15-20 mg with 5 mCi) for a one week evaluation and then a therapeutic dose of 685 mg unlabeled anti-B1 prior to optimize targeting of the radioactive antibody. Patient received radioimmunotherapy from 25 to 85 cGy. The median complete remission response was 16 months with a range of four to 38 months. Non-hematologic side effects in the study were minimal and myelosuppression was the dose-limiting toxicity. A mid-1997 NDA filing is planned...

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