Calaspargase pegol-mknl

(Asparlas®)

Calaspargase pegol-mknl

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 3,750 units/5 mL)
Drug ClassAsparagine 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.

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Summary
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  • Calaspargase pegol-mknl (Asparlas) is 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. It plays a pivotal role in improving survival rates, especially among children.
  • Two studies were analyzed which compared Asparlas with other forms of asparaginase, focusing on safety and effectiveness across different populations and subgroups.
  • The success rate of Asparlas-containing regimens has been substantial in treating pediatric acute lymphoblastic leukemia (ALL), with overall survival rates reaching up to 90%. Trials incorporating this drug have also been pursued for adolescents and young adults due to poor outcomes from conventional cytotoxic regimens.
  • Safety considerations are crucial due to associated toxicities such as hypersensitivity, thromboembolism, pancreatitis, osteonecrosis. However, it may result in similar or slightly reduced adverse effects compared to PEG-asparaginase, indicating a potentially safer profile, particularly in reducing leukemia relapse.
  • Population considerations indicate that Calaspargase pegol-mknl contributes significantly towards high ALL survival rates in pediatric patients, ongoing exploration in adolescents and young adults, and requires adjustments based on risk stratification for varied disease risk groups since dosing changes did not affect overall survival but had implications on toxicity profiles.
  • Despite promising results regarding the efficacy and safety profile, including reduction in leukemia relapse by calaspargase pegol-mknl versus PEG-asparaginase, more high-quality research is required across diverse patient cohorts before definitive conclusions can be drawn about these treatments concerning their benefits and harms.

Product Monograph / Prescribing Information

Document TitleYearSource
Asparlas (calaspargase pegol-mknl) Prescribing Information.2023Servier Pharmaceuticals LLC., Boston, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Pegaspargase in practice: minimizing toxicity, maximizing benefit.2021Current Hematologic Malignancy Reports
Acute lymphoblastic leukemia, version 2.2021, NCCN clinical practice guidelines in oncology.2021Journal of the National Comprehensive Cancer Network
Pediatric acute lymphoblastic leukemia, version 2.2020.2020Journal of the National Comprehensive Cancer Network