Pharmacological and clinical monitoring in children with acute lymphoblastic leukemia treated with a biogeneric PEG‐l‐asparaginase product

Background l‐Asparaginase (ASP) plays a crucial role in the treatment of childhood acute lymphoblastic leukemia (ALL). Currently, different ASP products are available in the market, including both native and pegylated drugs. Several biogeneric Escherichia coli ASP (GEN‐ASP) products have been develo...

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Published in:Pediatric blood & cancer 2022-09, Vol.69 (9), p.e29753-n/a
Main Authors: Matteo, Cristina, Colombini, Antonella, Bettini, Laura Rachele, Porcu, Luca, Barzaghi, Silvia, Ceruti, Tommaso, Silvestri, Daniela, Amoroso, Angela, Dell'Acqua, Fabiola, Gotti, Giacomo, Nastasi, Claudia, Zucchetti, Massimo, Rizzari, Carmelo
Format: Article
Language:English
Subjects:
Acute lymphoblastic leukemia
Asparaginase
biogeneric product
Chemotherapy
childhood acute lymphoblastic leukemia
Children
Escherichia coli
Hematology
Hypersensitivity
innovator product
Leukemia
Oncology
Patients
Pediatrics
pegylated asparaginase
Remission
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Summary:Background l‐Asparaginase (ASP) plays a crucial role in the treatment of childhood acute lymphoblastic leukemia (ALL). Currently, different ASP products are available in the market, including both native and pegylated drugs. Several biogeneric Escherichia coli ASP (GEN‐ASP) products have been developed in response to shortages and expensiveness of the native E. coli ASP innovator compounds, but some concerns have been raised about their quality. Recently, a number of generic pegylated ASP products (GEN‐PEG‐ASP) have been marketed to substitute for the innovator product (PEG‐ASP). Methods Clinical courses and serum asparaginase activity (SAA) levels were monitored in 12 children with ALL, who were treated in our institution with two doses of a GEN‐PEG‐ASP product, given IV at 2500 IU/m2 during the remission induction phase. Results were compared with those obtained in a reference cohort of 35 patients treated in our institution, who received the innovator PEG‐ASP product at same dosage and within the same chemotherapy background. Results Compared to the reference cohort treated with PEG‐ASP, SAA levels were significantly lower in the 12 patients receiving GEN‐PEG‐ASP (p 
ISSN:1545-5009
1545-5017
DOI:10.1002/pbc.29753