FDA药物批准简介:pegaspargase (oncaspar)的一线治疗儿童急性淋巴细胞白血病(ALL)。

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Dinndorf PA, Gootenberg J,科恩MH,基冈P, Pazdur R

FDA药物批准简介:pegaspargase (oncaspar)的一线治疗儿童急性淋巴细胞白血病(ALL)。

肿瘤学家。2007年8月,12 (8):991 - 8。

PubMed ID

17766659 (在PubMed

]

文摘

7月24日,2006年,美国食品和药物管理局批准pegaspargase (Oncaspar;Enzon制药公司,布里奇沃特,新泽西;此后,O)患者的一线治疗急性淋巴细胞白血病(ALL)作为化学治疗方案的一个组成部分。O曾在1994年2月批准治疗所有患者对原生形式的L-asparaginase极为敏感。审判支持这个新的指示是一个开放的标签、随机、多中心临床试验,招收了118名儿童(年龄,1 - 9岁)以前未经治疗的,标准的所有风险。患者接受本地大肠杆菌天冬酰胺酶(Elspar;默克公司怀特豪斯,新泽西;化学治疗以后,E)或O在缓解感应和延迟强化(DI)阶段的治疗。啊,在一个剂量的2500 IU / m(2),是管理贝聿铭在3天的四周感应阶段和3天的两个8周DI阶段。E,剂量的6000 IU / m(2),每周至少三次是贝聿铭管理九剂量在感应和六个剂量在每个阶段。 This study allowed direct comparison of O and E for asparagine depletion, asparaginase activity, and development of asparaginase antibodies. An unplanned comparison of event-free survival (EFS) was conducted to rule out a deleterious O efficacy effect. Following induction and DI treatment there was complete (0.03 IU/ml in O-treated subjects was greater than the number of days in E-treated subjects during both the induction and DI phases of treatment. There was no correlation, however, between asparaginase activity and serum asparagine levels, making the former determination less clinically relevant. Using the protocol-prespecified threshold for a positive result of >2.5 times the control, 7 of 56 (12%) O subjects tested at any time during the study demonstrated antiasparaginase antibodies and 16 of 57 (28%) E subjects tested at any time during the study had antiasparaginase antibodies. In both study arms EFS was in the range of 80% at 3 years. The most serious, sometimes fatal, O toxicities were anaphylaxis, other serious allergic reactions, thrombosis (including sagittal sinus thrombosis), pancreatitis, glucose intolerance, and coagulopathy. The most common adverse events were allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases. Disclosure of potential conflicts of interest is found at the end of this article.

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药物靶点

药物	目标	类	生物	药理作用	行动
Pegaspargase	L-asparagine	小分子	人类	是的	底物	细节