Drug updated on 9/4/2024
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
- Asparlas (calaspargase pegol-mknl) 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.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Event-Free Survival (EFS): In children and adolescents with acute lymphoblastic leukemia (ALL), studies comparing different doses of PEG-asparaginase and calaspargase showed little to no difference in EFS across various dosing regimens (e.g., RR 1.01, 95% CI 0.97 to 1.06; RR 1.06, 95% CI 0.97 to 1.16; moderate-certainty evidence).
- Overall Survival (OS): A study comparing six doses to two doses of PEG-asparaginase in children with standard low-risk ALL found little to no difference in OS (RR 0.99, 95% CI 0.98 to 1.00; moderate-certainty evidence).
- Leukaemic Relapse: Treatment with 11 doses of calaspargase versus 16 doses of PEG-asparaginase in children and adolescents with standard- and high-risk ALL likely reduces leukaemic relapse (RR 0.32, 95% CI 0.12 to 0.83; moderate-certainty evidence).
- Hypersensitivity: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in hypersensitivity compared to PEG-asparaginase (RR 1.17, 95% CI 0.64 to 2.13; low-certainty evidence).
- Pancreatitis: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in pancreatitis compared to PEG-asparaginase (RR 0.85, 95% CI 0.47 to 1.52; low-certainty evidence).
- Thromboembolism: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in thromboembolism compared to PEG-asparaginase (RR 0.83, 95% CI 0.48 to 1.42; low-certainty evidence).
- Osteonecrosis: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in osteonecrosis compared to PEG-asparaginase (RR 0.63, 95% CI 0.15 to 2.56; low-certainty evidence).
- Overall Asparaginase-Associated Toxicity: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in overall asparaginase-associated toxicity compared to PEG-asparaginase (RR 1.00, 95% CI 0.71 to 1.40; low-certainty evidence).
- The evidence indicates that the studies primarily focused on children and adolescents with ALL, aged 1.0 to 21.0 years, with a specific subgroup analysis for children aged one to nine years in standard low-risk ALL. Outcomes were stratified by dosing regimens, showing age-dependent differences where children generally had better survival rates compared to older populations. These findings were observed across standard and high-risk ALL and lymphoblastic lymphoma populations.
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: Targets and Therapy |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Pegaspargase in practice: minimizing toxicity, maximizing benefit. | 2021 | Current Hematologic Malignancy Reports |
Acute lymphoblastic leukemia, version 2.2021, NCCN clinical practice guidelines in oncology. | 2021 | Journal of the National Comprehensive Cancer Network |
Pediatric acute lymphoblastic leukemia, version 2.2020. | 2020 | Journal of the National Comprehensive Cancer Network |