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.
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Summary of Cancellation for Opdivo
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Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
2018-01-19
What was the purpose of this submission?
The purpose of the supplemental new drug submission (SNDS) was to seek the authorization of Opdivo (nivolumab) for use in patients with locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
What did the company submit to support its submission?
The sponsor submitted study CA2090275 (aka CheckMate-275), which was an open-label, single-arm study of nivolumab monotherapy in patients with locally advanced or metastatic urothelial carcinoma who had prior treatment with a platinum based treatment regimen. Additional early phase clinical data was also submitted as support as well as clinical safety data obtained from trials conducted in patients with a wide variety of cancer types.
Phase 3 trial data was not part of the submission.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
The review of the submitted clinical information was complete. Health Canada identified a critical deficiency (i.e., the lack of phase 3 trial data) that would have precluded issuing an approval. The sponsor chose to cancel 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?
There is no expected impact for patients using SAP or in clinical trials.
Requests for special access to nivolumab will continue to be considered on a case-by-case basis. For more information, refer to the Special Access Programme web site.
There are two approved clinical trials underway in Canada for the use of nivolumab in the treatment of patients with urothelial carcinoma. No impact is expected for patients participating in these studies.