FDA Drug Approval Summary: Pegaspargase (Oncaspar®) for the First-Line Treatment of Children with Acute Lymphoblastic Leukemia (ALL)

Author:

Dinndorf Patricia Anne1,Gootenberg Joseph1,Cohen Martin H.1,Keegan Patricia1,Pazdur Richard1

Affiliation:

1. Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

Abstract

Learning Objectives After completing this course, the reader will be able to: Describe the effect of pegylation on asparaginase pharmacokinetics and immunogenicity.Identify the current pegaspargase indications.Discuss the advantages of pegaspargase treatment.Outline the clinical trial design leading to pegaspargase approval by the FDA.List the major adverse events associated with pegaspargase treatment. CME Access and take the CME test online and receive 1 AMA PRA Category 1 Credit™ at CME.TheOncologist.com

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

Reference16 articles.

1. Evidence that the L-asparaginase activity of guinea pig serum is responsible for its antilymphoma effects;Broome;Nature,1961

2. E. coli L-asparaginase in treatment of leukemia and solid tumors in 131 children;Tallal;Cancer,1970

3. Optimal use of L-asparaginase (NSC-109229) in acute lymphocytic leukemia;Jones;Med Pediatr Oncol,1977

4. Effective dose of L-asparaginase for induction of remission in previously treated children with acute lymphocytic leukemia: A report from Children's Cancer Study Group;Ertel;Cancer Res,1979

5. Four-agent induction and intensive asparaginase therapy for treatment of childhood acute lymphoblastic leukemia;Clavell;N Engl J Med,1986

Cited by 250 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3