Summary of Cancellation for Asparaginase Erwinia Chrysanthemi (Erwinase)
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Contact:
Medicinal ingredient(s):
Asparaginase Erwinia Chrysanthemi
Therapeutic area:
Antineoplastic agent
Type of submission:
New Drug Submission (Priority Review)
Control number:
255132
Decision issued:
The company cancelled its submission before a final decision was issued.
Date of cancellation:
2023-07-19
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek authorization of Erwinase (Asparaginase Erwinia Chrysanthemi for injection) which is indicated in combination with other chemotherapeutic agents to treat patients, principally children, with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity (clinical allergy or silent inactivation) to E. coli asparaginase or pegylated asparaginase obtained from E. coli.
What did the company submit to supports its submission?
The sponsor submitted drug quality, pre-clinical and clinical components. Following the initial review of the NDS, a Notice of Deficiency (NOD) from a quality perspective was issued by Health Canada on May 31, 2022. A NOD response was provided by the company on March 31, 2023, and an NOD-Withdrawal (NOD-W) was recommended by the Health Canada.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, Health Canada had not completed the review of the quality data provided to support the submission as concerns were identified that led to the issuance of an NOD. The quality data submitted in response to the NOD were inadequate to address the concerns identified. The sponsor chose to cancel the submission without prejudice to refiling. At the time of cancellation, the non-clinical and clinical review by Health Canada was also not yet completed.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is currently another authorized product, Rylaze, for the same indication as Erwinase.
For more information about the Special Access Programme refer to the programme’s Web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas.
There are currently no approved clinical trials underway in Canada using Erwinase.
*Proposed Brand Name:
Erwinase
Manufacturer:
Porton Biopharma Ltd.
Drug Identification Numbers issued:
N/A
Date filed:
July 27, 2021