Regulatory Decision Summary for Asparlas
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):
Calaspargase pegol for injection
Control Number:
268282
Therapeutic Area:
Antineoplastic Agents
Type of Submission:
New Drug Submission
Decision issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of this submission is to seek market authorization for Asparlas as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia.
After evaluation of the submitted data package, Health Canada authorized Asparlas as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 to 21 years.
Why was the decision issued?
Authorization was based on two multicentre, randomized, controlled studies, DFC 11-001 and AALL07P4, in pediatric (≥ 1 year of age) or young adult patients with newly diagnosed acute lymphoblastic leukemia (ALL).
The efficacy of Asparlas was determined based on the achievement and maintenance of nadir serum asparaginase activity ≥ 0.1 IU/mL in patients treated with Asparlas 2,500 IU/m2. Following a single dose administration of 2,500 IU/m2 in Study AALL07P4, the majority of patients achieved asparaginase activity ≥ 0.1 IU/mL on Day 18 and Day 25. The NSAA level is expected to be maintained in 99% of the patients receiving Asparlas 2,500 IU/m2 Q3W based on modelling and simulation results.
In Study DFCI 11-001, the most common adverse reactions reported in ≥ 20% of patients treated with Asparlas were hypoalbuminemia, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, hypertriglyceridemia, hyperglycemia, and blood fibrinogen decreased. The safety findings between in the Asparlas group were generally similar to those in the pegaspargase group. No new asparaginase-related adverse reactions were observed. In Study AALL07P4, adverse events associated with asparaginase were generally increased in the Asparlas group, compared to the pegaspargase group. This uncertainty is adequately managed via labelling (i.e., risks are described in the Product Monograph) and enhanced post-market surveillance for Asparlas.
Overall, based on the evidence reviewed, the anticipated benefit of Asparlas outweighs the potential risks and remaining uncertainties as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL in pediatric and young adult patients age 1 to 21 years. A Notice of Compliance is recommended.
The recommended dose of Asparlas is 2,500 IU/m2 administered as intravenous infusion no more frequently than every 21 days.
An updated Risk Management Plan (RMP) for Asparlas was reviewed by Health Canada and considered acceptable.
The chemistry and manufacturing information submitted for Asparlas has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
A Notice of Compliance was recommended.
For further details about Asparlas, please refer to the Product Monograph, approved by Health Canada and available through the .Drug Product Database
Date of Decision:
2023-11-08
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
02542943
Prescription status:
Available by prescription only
Date Filed:
2022-09-29
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ASPARLAS | 02542943 | SERVIER CANADA INC | CALASPARGASE PEGOL 3750 UNIT / 5 ML |