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:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
Yervoy (ipilimumab for injection) is currently authorized as a single agent or in combination with Opdivo (nivolumab) for the treatment of adult patients with unresectable or metastatic melanoma and metastatic Renal Cell Carcinoma (RCC).
Based on previously reviewed submissions, and authorized indications of use for the combination of Yervoy plus nivolumab, the Sponsor requested the incorporation of the following uses of ipilimumab in the Yervoy Product Monograph (PM):
Indications for Yervoy, in combination with nivolumab for: unresectable or metastatic melanoma, metastatic Non-Small Cell Lung Cancer (NSCLC), microsatellite Instability-High (MSI-H)/ mismatch Repair Deficient (dMMR) metastatic Colorectal Cancer, and unresectable Malignant Pleural Mesothelioma (MPM).
Safety information regarding the risk of aplastic anemia.
Why was the decision issued?
No new supporting clinical data was provided. Authorization was based on information that has been previously reviewed and authorized for Opdivo for the combination with ipilimumab. This was acceptable.
All relevant changes to the Yervoy PM were in alignment with the approved Opdivo PM, dated July 12, 2021, for the combination use.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations