Regulatory Decision Summary for Opdivo
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:
Summary of Cancellation for Opdivo (Control number 204349)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
The sponsor, Bristol-Myers Squibb Canada Co., cancelled the submission before a final decision was issued by Health Canada.
Date of cancellation
April 15, 2019
What was the purpose of this submission?
The sponsor filed a Supplemental New Drug Submission - Confirmatory (SNDS-c) for Opdivo (nivolumab) to fulfill the commitments for the following indications authorized under the Notice of Compliance with conditions (NOC/c) policy:
- Opdivo is indicated for the treatment of adult patients with previously untreated unresectable or metastatic BRAF V600 mutation positive melanoma.
An improvement in survival has not yet been established. - Opdivo is indicated for the treatment of adult patients with previously untreated unresectable or metastatic melanoma 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 tumor PD-L1 expression (based on the predefined expression level of < 5%). An improvement in survival has not yet been established.
What did the company submit to support its submission?
The efficacy and safety results from a phase III clinical trial in patients with previously untreated, unresectable or metastatic melanoma were provided.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
After review of the data provided, Health Canada considered that the data were insufficient and a comprehensive benefit/risk assessment could not be concluded. Subsequently, a Notice of Deficiency (NOD) was issued. The sponsor filed a response to the NOD with updated clinical data, as requested by Health Canada. At the time that the sponsor cancelled the submission, Health Canadas review was ongoing and the benefit/risk assessment on the combination therapy of Opdivo with ipilimumab remained unresolved. The sponsor chose to voluntarily withdraw their submission without prejudice to refiling."
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
The conditional approval of the indications is unchanged. There is no impact on the access of the drug. Under the NOC/c policy, the sponsor commits to submit clinical efficacy and safety data to verify the clinical benefit of the indications authorized with conditions.
Additional information
*Proposed Brand Name
Opdivo