Expert opinion on biological therapy · 2012
Erwinia asparaginase in pediatric acute lymphoblastic leukemia.
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Salzer Wanda, Seibel Nita, Smith Malcolm
Аннотация
INTRODUCTION: Asparaginase is a major a component of therapy for acute lymphoblastic leukemia (ALL) and has been used for over 40 years. Hypersensitivity reactions limit the use and efficacy of asparaginase products. However, Erwinia asparaginase gained the Food and Drug Administration (FDA) approval in November 2011, for use in patients with allergic reactions to Escherichia coli-derived asparaginase.
AREAS COVERED: Erwinia asparaginase is an enzyme that hydrolyzes the amino acid asparagine. This review examines the properties of Erwinia asparaginase compared to the two other preparations of asparaginase available for use in the United States. Results of selected clinical trials involving Erwinia asparaginase, including the pivotal study resulting in FDA approval, are presented.
EXPERT OPINION: Erwinia asparaginase is well tolerated, and it is effective in achieving asparaginase levels associated with efficacy in the treatment of ALL. With FDA approval of Erwinia asparagainse, oncologists now have an alternative for ALL patients who become hypersensitive to E. coli-derived asparaginase. Future studies will be needed to establish optimal dosing of Erwinia asparaginase (e.g., intravenous vs. intramuscular) and to better define the most appropriate indications for its use in patients previously treated with E. coli-derived asparaginase.
AREAS COVERED: Erwinia asparaginase is an enzyme that hydrolyzes the amino acid asparagine. This review examines the properties of Erwinia asparaginase compared to the two other preparations of asparaginase available for use in the United States. Results of selected clinical trials involving Erwinia asparaginase, including the pivotal study resulting in FDA approval, are presented.
EXPERT OPINION: Erwinia asparaginase is well tolerated, and it is effective in achieving asparaginase levels associated with efficacy in the treatment of ALL. With FDA approval of Erwinia asparagainse, oncologists now have an alternative for ALL patients who become hypersensitive to E. coli-derived asparaginase. Future studies will be needed to establish optimal dosing of Erwinia asparaginase (e.g., intravenous vs. intramuscular) and to better define the most appropriate indications for its use in patients previously treated with E. coli-derived asparaginase.