Erwinase (crisantaspase)
Registration timeline
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced
| 30 September 2021
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 31 October 2023
|
Advisory Committee meeting | 30 November and 1 December 2023
|
Registration decision (Outcome) | 6 February 2024
|
Completion of administrative activities and registration on ARTG | 14 February 2024
|
Number of working days from submission dossier acceptance to registration decision* | 228
|
*Statutory timeframe for standard applications is 255 working days
The same dosage recommendations apply to paediatric and adult patients.
To substitute for a dose of pegaspargase: The recommended dose for each planned dose of pegaspargase is 25,000 international units/m2 administered intramuscularly or intravenously three times a week (Monday/Wednesday/Friday) for six doses.
For further information refer to the Product Information
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your state or territory.
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.
Erwinase (crisantaspase) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Erwinase must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
The Erwinase EU [European Union] risk management plan (RMP) (version 1.1, dated 10 February 2021, data lock point 30 April 2020), with Australia-specific annex (version 1.2, dated 3 March 2023), included with Submission PM-2021-03236-1-6, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Further information
The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.