How is it different from pegaspargase?

It uses a more stable PEG linker that gives a longer half-life, so it can be dosed less frequently (for example every 3 weeks) while maintaining asparagine depletion.

How does asparaginase kill leukaemia cells?

It depletes the amino acid asparagine from the blood. Leukaemic cells cannot make enough of their own, so they are starved of asparagine and die, while normal cells largely cope.

What are the major risks?

The asparaginase toxicity class: allergic reactions including anaphylaxis, pancreatitis, blood clots and bleeding, liver toxicity, and high blood sugar. It requires close hospital monitoring.

Is it something a patient can obtain or use on their own?

No. It is a prescription intravenous chemotherapy component administered only by oncology teams as part of a full leukaemia treatment protocol.

EMA-approved

Calaspargase pegol — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Calaspargase pegol is a peptide catalogued under Enzymes. Neutral reference entry; EU status: EU-approved prescription medicine.

What is Calaspargase pegol?

Calaspargase pegol (brand name Asparlas) is a long-acting PEGylated form of the enzyme E. coli L-asparaginase, given intravenously as a component of multi-agent chemotherapy.

The US FDA approved it in December 2018 for acute lymphoblastic leukaemia (ALL) in pediatric and young-adult patients, based on achievement of and maintenance of target nadir serum asparaginase activity.

Its longer half-life allows less frequent dosing than standard pegaspargase; it is a prescription hospital drug, not a peptide for research or personal use.

How does Calaspargase pegol work?

Asparaginase depletes circulating asparagine, and leukaemic lymphoblasts cannot synthesize enough asparagine themselves, so they are starved of this amino acid and die.

PEGylation with a stable linker extends the enzyme's half-life, sustaining asparagine depletion over a longer interval.

What does the research say about Calaspargase pegol?

Calaspargase pegol maintains asparaginase enzyme activity substantially longer than pegaspargase, allowing a longer dosing interval while still achieving sustained asparagine depletion (COG AALL07P4). ^[1]
FDA approval in 2018 was supported by calaspargase pegol achieving and maintaining the target nadir serum asparaginase activity threshold as part of multi-agent ALL chemotherapy. ^[2]
In the randomized DFCI 11-001 trial, calaspargase pegol every 3 weeks gave comparable efficacy and a similar toxicity profile to pegaspargase every 2 weeks in childhood ALL. ^[3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

[1] Pharmacokinetic and pharmacodynamic properties of calaspargase pegol Escherichia coli L-asparaginase in the treatment of patients with acute lymphoblastic leukemia: results from Children's Oncology Group Study AALL07P4 — Angiolillo AL et al., Journal of Clinical Oncology 2014. (Randomized pharmacokinetic phase 2 study)
[2] FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults — Li RJ et al., Clinical Cancer Research 2020. (Regulatory review / FDA approval summary)
[3] Efficacy and Toxicity of Pegaspargase and Calaspargase Pegol in Childhood Acute Lymphoblastic Leukemia: Results of DFCI 11-001 — Vrooman LM et al., Journal of Clinical Oncology 2021. (Randomized phase 3 trial)
[4] PEG-asparaginase treatment regimens for acute lymphoblastic leukaemia in children: a network meta-analysis — Lynggaard LS et al., Cochrane Database of Systematic Reviews 2023. (Systematic review / network meta-analysis)
[5] A 12-Step Desensitization Protocol for Calaspargase Pegol-mknl — Nguyen MHN et al., Journal of Pediatric Pharmacology and Therapeutics 2025. (Clinical protocol / case description)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

Calaspargase pegol is given by intravenous infusion on a fixed interval as one part of a multi-drug leukaemia regimen, always within specialist oncology care.

Exact dosing, intervals, and monitoring are determined by the treating oncology team and are outside the scope of encyclopedic information.

Side effects & safety profile

It carries the characteristic asparaginase toxicity class: hypersensitivity and anaphylaxis, pancreatitis, thrombosis and bleeding, and hepatotoxicity.

Hyperglycemia and elevated liver enzymes are also common, and serious hypersensitivity may require desensitization or switching agents.

It is a hospital-administered oncology drug requiring close monitoring; it is prescription-only and has no legitimate non-clinical use.

Stacking & combinations

It is used only as a component of multi-agent chemotherapy regimens for ALL, never as a standalone or self-directed agent.

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Frequently asked questions

Yes. The FDA approved it (brand Asparlas) in December 2018 for acute lymphoblastic leukaemia in pediatric and young-adult patients as a component of multi-agent chemotherapy.

References

[1] Pharmacokinetic and pharmacodynamic properties of calaspargase pegol Escherichia coli L-asparaginase in the treatment of patients with acute lymphoblastic leukemia: results from Children's Oncology Group Study AALL07P4 — Angiolillo AL et al., Journal of Clinical Oncology 2014. PMID: 25348002. View sourceStudy: Randomized pharmacokinetic phase 2 studyCalaspargase pegol showed a longer half-life and sustained asparaginase activity versus pegaspargase.
[2] FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults — Li RJ et al., Clinical Cancer Research 2020. PMID: 31444252. View sourceStudy: Regulatory review / FDA approval summarySummarizes the pharmacologic basis for the 2018 FDA approval in pediatric and young-adult ALL.
[3] Efficacy and Toxicity of Pegaspargase and Calaspargase Pegol in Childhood Acute Lymphoblastic Leukemia: Results of DFCI 11-001 — Vrooman LM et al., Journal of Clinical Oncology 2021. PMID: 34228505. View sourceStudy: Randomized phase 3 trialCalaspargase pegol every 3 weeks matched pegaspargase every 2 weeks on efficacy and toxicity in childhood ALL.
[4] PEG-asparaginase treatment regimens for acute lymphoblastic leukaemia in children: a network meta-analysis — Lynggaard LS et al., Cochrane Database of Systematic Reviews 2023. PMID: 37260073. View sourceStudy: Systematic review / network meta-analysisCompared PEG-asparaginase regimens, informing dosing and toxicity trade-offs in pediatric ALL.
[5] A 12-Step Desensitization Protocol for Calaspargase Pegol-mknl — Nguyen MHN et al., Journal of Pediatric Pharmacology and Therapeutics 2025. PMID: 39935556. View sourceStudy: Clinical protocol / case descriptionDescribes a desensitization approach for patients with hypersensitivity to calaspargase pegol.

This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.