Regulatory Decision Summary for Yervoy
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):
ipilimumab
Control Number:
270801
Therapeutic Area:
Antineoplastic
Type of Submission:
Supplement to a 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 was to include a new indication for Yervoy in combination with Opdivo for the treatment of patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Additionally, this submission sought to integrate an alternate flat-dose regimen of Opdivo in combination with Yervoy for patients with metastatic non-small cell lung cancer (NSCLC) within the Yervoy product monograph. Both the new indication and the flat-dose regimen were authorized for Opdivo in 2022.
Why was the decision issued?
The combination therapy of Opdivo and Yervoy exhibited a favorable benefit-risk profile, leading Health Canada to authorize the use of Opdivo for the treatment of patients with unresectable and metastatic ESCC. The flat-dose regimen of Opdivo, in combination with Yervoy, demonstrated both clinical benefit and a manageable safety profile for treating patients with metastatic NSCLC, leading to its authorization. The benefit-risk profile of the combination therapy will not be affected with the incorporation of this indication and dosing regimen for Yervoy.
After its authorization in several countries, Yervoy has been found to be associated with a high incidence of myelitis. The product monograph was updated in this submission to include myelitis in the “Warnings and Precautions” section to mitigate its risk.
Based on the data reviewed, the benefit-risk profile for Yervoy, in combination with Opdivo, remains favorable for the treatment of patients with unresectable and metastatic ESCC and metastatic NSCLC.
A Notice of Compliance (NOC) is recommended.
For further details about Yervoy please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2023-12-07
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription status:
Schedule D drug
Date Filed:
2022-12-19
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| YERVOY | 02379384 | BRISTOL-MYERS SQUIBB CANADA | IPILIMUMAB 5 MG / ML |