FDA drug approval summary: Alemtuzumab as single-agent treatment for B-Cell chronic lymphocytic leukemia
FDA drug approval summary: Alemtuzumab as single-agent treatment for B-Cell chronic lymphocytic leukemia
复制标题
DOI：
10.1634/theoncologist.2007-0218
复制
发表时间：
2008-01-01
期刊：
影响因子：
5.8
通讯作者：
Pazdur, Richard
中科院分区：
文献类型：
--
作者：
Demko, Suzanne;Summers, Jeffrey;Pazdur, Richard
2007年9月19日，美国国务院宣布，S.美国食品药品监督管理局（FDA）批准了阿仑单抗（Campath（R）; Genzyme Corporation，剑桥，MA）作为B细胞慢性淋巴细胞白血病（B-CLL）单药治疗的常规批准和扩展标签。Alemtuzumab最初于2001年根据加速批准法规获得批准。转换为常规批准是基于提交的单一研究，以验证临床获益。在一项开放标签、国际、多中心、随机化试验中证实了疗效和安全性，该试验纳入了297例既往未经治疗的Rai I-IV期B-CLL患者，这些患者的疾病进展。患者随机接受阿仑单抗30 mg静脉注射，每周3次，每次2小时，隔日给药，最长12周，或苯丁酸氮芥40 mg/m2口服，每28天给药，最长12个月。阿仑单抗组的无进展生存时间（主要研究终点）明显长于苯丁酸氮芥组。阿仑单抗组的总体缓解率和完全缓解率也明显更高。未观察到生存期差异。在接受Alemtuzumab治疗的患者中未发现新的安全性信号。Alemtuzumab的最严重（有时是致死性）毒性为血细胞减少、输注反应和感染。
On September 19, 2007, the U. S. Food and Drug Administration granted regular approval and expanded labeling for alemtuzumab (Campath((R)); Genzyme Corporation, Cambridge, MA) as single-agent treatment for B-cell chronic lymphocytic leukemia (B-CLL). Alemtuzumab was initially approved in 2001 under accelerated approval regulations. Conversion to regular approval was based on a single study submitted to verify clinical benefit. Efficacy and safety were demonstrated in an open-label, international, multicenter, randomized trial of 297 patients with previously untreated, Rai stage I-IV B-CLL experiencing progression of their disease. Patients were randomized to either alemtuzumab, 30 mg i.v. over 2 hours three times per week on alternate days for a maximum of 12 weeks, or chlorambucil, 40 mg/m(2) orally every 28 days for a maximum of 12 months. The progression-free survival time, the primary study endpoint, was significantly longer in the alemtuzumab arm than in the chlorambucil arm. Both the overall and complete response rates were also significantly higher in the alemtuzumab arm. No differences in survival were observed. There were no new safety signals identified in patients receiving alemtuzumab. The most serious, and sometimes fatal, toxicities of alemtuzumab are cytopenias, infusion reactions, and infections.