Charles P Theuer, Bryan R Leigh, Pratik S Multani, Roberta S Allen, Bertrand C Liang
{"title":"Radioimmunotherapy of non-Hodgkin's lymphoma: clinical development of the Zevalin regimen.","authors":"Charles P Theuer, Bryan R Leigh, Pratik S Multani, Roberta S Allen, Bertrand C Liang","doi":"10.1016/S1387-2656(04)10011-2","DOIUrl":null,"url":null,"abstract":"<p><p>Zevalin (ibritumomab tiuxetan; IDEC Pharmaceuticals Corporation, San Diego, CA, USA) was approved by the United States Food and Drug Administration on February 19, 2002, following 9 years of clinical development. Six clinical studies supported the Zevalin Biologics License Application. The Zevalin regimen is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL), and for those with follicular NHL refractory to Rituxan (rituximab, MabThera; IDEC Pharmaceuticals Corporation, San Diego, CA and Genentech, South San Francisco, CA). In the year following FDA approval, approximately 1300 patients were treated in clinical trials or with the commercially available product.</p>","PeriodicalId":79566,"journal":{"name":"Biotechnology annual review","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1387-2656(04)10011-2","citationCount":"20","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biotechnology annual review","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/S1387-2656(04)10011-2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 20
Abstract
Zevalin (ibritumomab tiuxetan; IDEC Pharmaceuticals Corporation, San Diego, CA, USA) was approved by the United States Food and Drug Administration on February 19, 2002, following 9 years of clinical development. Six clinical studies supported the Zevalin Biologics License Application. The Zevalin regimen is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL), and for those with follicular NHL refractory to Rituxan (rituximab, MabThera; IDEC Pharmaceuticals Corporation, San Diego, CA and Genentech, South San Francisco, CA). In the year following FDA approval, approximately 1300 patients were treated in clinical trials or with the commercially available product.
泽伐林;IDEC制药公司(San Diego, CA, USA)经过9年的临床开发,于2002年2月19日获得美国食品和药物管理局批准。6项临床研究支持泽伐林生物制剂许可申请。Zevalin方案适用于治疗复发或难治性低级别、滤泡性或转化性b细胞非霍奇金淋巴瘤(NHL)患者,以及对利妥昔单抗(rituximab, MabThera;IDEC制药公司,圣地亚哥,加州和基因泰克,南旧金山,加州)。在FDA批准后的一年中,大约有1300名患者在临床试验或市售产品中接受治疗。