Artigo Revisado por pares

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

2007; AlphaMed Press; Volume: 12; Issue: 8 Linguagem: Inglês

10.1634/theoncologist.12-8-991

ISSN

1549-490X

Autores

Patricia A. Dinndorf, Joseph E. Gootenberg, Martin H. Cohen, Patricia Keegan, Richard Pazdur,

Tópico(s)

Pharmaceutical studies and practices

Resumo

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

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