Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 3,750 units/5 mL) |
Drug Class | Asparagine specific enzymes |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients aged 1 month to 21 years.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- No significant difference in Event-Free Survival (EFS) or Overall Survival (OS) was observed between intermittent PEG-asparaginase (eight doses) and continuous PEG-asparaginase (15 doses) in non-high risk acute lymphoblastic leukemia (ALL) patients, as well as between low-risk standard treatment with additional PEG-asparaginase (six doses) and standard treatment (two doses), with risk ratios (RR) close to 1.
- Calaspargase (11 doses) showed a significant reduction in leukemic relapse compared to PEG-asparaginase (16 doses) with an RR of 0.32 (95% confidence interval (CI): 0.12 to 0.83), but no significant difference in EFS (RR 1.06).
- PEG-asparaginase administered intermittently (eight doses) compared to continuous treatment (15 doses) was associated with reduced pancreatitis (RR 0.31) and asparaginase-associated toxicity (RR 0.53), but possible reduction in hypersensitivity (RR 0.64) and thromboembolism (RR 0.55) showed less conclusive results.
- In comparison, adding PEG-asparaginase to low-risk standard treatment increased hypersensitivity (RR 12.05) and pancreatitis (RR 4.84) without a significant difference in thromboembolism or osteonecrosis.
- PEG-asparaginase was primarily studied in children and adolescents aged 1.0 to 17.9 years with non-high risk acute lymphoblastic leukemia (ALL) and in participants aged 1 to 9 years with low-risk ALL. Additionally, Calaspargase was studied in adolescents and young adults (AYA) up to 21 years old with standard- and high-risk ALL and lymphoblastic lymphoma, showing reduced leukemic relapse compared to PEG-asparaginase in this group.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Asparlas (calaspargase pegol-mknl) Prescribing Information. | 2023 | Servier Pharmaceuticals LLC, Boston, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
PEG-asparaginase treatment regimens for acute lymphoblastic leukaemia in children: a network meta-analysis | 2023 | The Cochrane Database of Systematic Reviews |
Asparaginase in the Treatment of Acute Lymphoblastic Leukemia in Adults: Current Evidence and Place in Therapy | 2022 | Blood and Lymphatic Cancer |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Pediatric acute lymphoblastic leukemia, version 2.2020. | 2020 | Journal of the National Comprehensive Cancer Network |