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.
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What was the purpose of this submission?
The purpose of this Supplemental New Drug Submission is to update the Yervoy product monograph to include the indication of combination therapy of Yervoy and Opdivo (nivolumab) which was authorized by Health Canada under the Notice of Compliance with conditions (NOC/c) pathway in October 2016. The following NOC/c indication was added to the Yervoy product monograph: "Opdivo is indicated for the treatment of patients with unresectable or metastatic melanoma in previously untreated adults when used in combination with ipilimumab. Relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with ipilimumab is established only in patients with low tumour PD-L1 expression (based on the predefined expression level of < 5%). An improvement in survival has not yet been established." The updated Yervoy (ipilimumab) product monograph refers health care professionals to the Opdivo product monograph in the appropriate locations for complete efficacy and safety details of this combination therapy.
Why was the decision issued?
This Supplemental New Drug Submission (SNDS) did not include any new efficacy or safety data for review. There is no change to the benefit/risk assessment for the use of Yervoy as a single agent in the treatment of unresectable or metastatic melanoma, which was authorized through a Notice of Compliance in February 2012. There is no change to the benefit/risk assessment for the use of Yervoy in combination with Opdivo for the treatment of unresectable or metastatic melanoma in previously untreated adults, which was authorized through a Notice of Compliance with Conditions in October 2016. This SNDS updated the Yervoy product monograph to include the recently authorized NOC/c indication and provides reference to the complete efficacy and safety data for the combination therapy in the Opdivo product monograph. Both Yervoy and Opdivo are marketed by Bristol Myers Squibb Canada.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| YERVOY | 02379384 | BRISTOL-MYERS SQUIBB CANADA | IPILIMUMAB 5 MG / ML |