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Other cytotoxics, enzymes and natural productsIn useDerivative of an earlier drug

Calaspargase pegol

Also known as Asparlas, calaspargase pegol-mknl, SC-PEG

A pegylated E. coli asparaginase that uses a different, more stable linker than pegaspargase and has a longer half-life. Given by infusion for acute lymphoblastic leukaemia in children and young adults.

From discovery to approval

  1. 2014 · Earliest report found

    The earliest report found is the Children's Oncology Group study AALL07P4 (2014), which compared calaspargase pegol (SC-PEG; succinimidyl carbamate linker between PEG and E. coli L-asparaginase) with pegaspargase (SS-PEG; succinimidyl succinate linker).[2][1]

  2. 2018-12-20 · FDA regular

    Original approval of BLA 761102 (letter signed 20 December 2018; Drugs@FDA lists 12/20/2018, orphan): as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukaemia in paediatric and young adult patients aged 1 month to 21 years (label). No conditional, exceptional or accelerated wording was found, so 'regular' is an inference.[3]

How it works

An enzyme that converts asparagine to aspartic acid and ammonia. The label says its effect is thought to rest on killing leukaemic cells with low asparagine synthetase, which depend on outside asparagine.[1]

Where it came from and why

The report says the carbamate linker creates a more stable molecule. The trial set out to show pharmacokinetic and pharmacodynamic comparability in newly diagnosed high-risk B-cell leukaemia; mean half-life of plasma asparaginase activity was about 2.5 times longer with SC-PEG.

Cancers

  • Acute lymphoblastic leukaemia

    The 2018 US label lists use as a component of a multi-agent regimen for acute lymphoblastic leukaemia in patients aged 1 month to 21 years.[1]

Family and partners

Derived from: Pegaspargase

Worth knowing

  • In the Dana-Farber ALL Consortium 11-001 randomised trial (239 eligible patients, 2012 to 2015), 5-year event-free survival was 84.9% with pegaspargase and 88.1% with calaspargase (P = .65); at day 25, 88% of patients with calaspargase and 17% with pegaspargase had serum asparaginase activity of at least 0.1 IU/mL (P < .001).[4]
  • A 2023 review says calaspargase pegol was approved by the FDA in 2018 and that its different linker gives a longer half-life and shelf life.[5]

References

  1. U.S. Food and Drug Administration. Asparlas (calaspargase pegol-mknl) prescribing information, BLA 761102, original approval December 2018. Source
  2. Angiolillo AL, Schore RJ, Devidas M, Borowitz MJ, Carroll AJ, Gastier-Foster JM, et al. 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. J Clin Oncol. 2014;32(34):3874-82. PubMedDOI
  3. U.S. Food and Drug Administration. Approval letter, BLA 761102 (Asparlas, calaspargase pegol-mknl), December 2018. Source
  4. Vrooman LM, Blonquist TM, Stevenson KE, Supko JG, Hunt SK, Cronholm SM, et al. Efficacy and Toxicity of Pegaspargase and Calaspargase Pegol in Childhood Acute Lymphoblastic Leukemia: Results of DFCI 11-001. J Clin Oncol. 2021;39(31):3496-3505. PubMedDOI
  5. Tong WH, Rizzari C. Back to the future: the amazing journey of the therapeutic anti-leukemia enzyme asparaginase Erwinia chrysanthemi. Haematologica. 2023;108(10):2606-2615. PubMedDOI
  6. U.S. Food and Drug Administration. Drugs@FDA: approval date(s) and history, letters, labels for BLA 761102 (Asparlas, calaspargase pegol-mknl). Page read 2026-10-29. Source