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Erwinase (crisantaspase)
Published
Product name
Erwinase
Active ingredient
Crisantaspase
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Erwinase (crisantaspase) was approved for the following therapeutic use:
Erwinase is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to pegylated asparaginase obtained from E. coli.
How this medicine works
Crisantaspase catalyzes the deamidation of asparagine to aspartic acid and ammonia, resulting in a reduction in circulating levels of asparagine. The mechanism of action of Erwinase is thought to be based on the inability of leukemic cells to synthesize asparagine due to lack of asparagine synthetase activity, resulting in cytotoxicity specific for leukemic cells that depend on an exogenous source of amino acid asparagine for their protein metabolism and survival.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Erwinase was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- 371877