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
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
November 29, 2019
What was the purpose of this submission?
The purpose of this Supplemental New Drug Submission (S/NDS) was to add a new indication for "the treatment of adult patients with advanced or recurrent gastric or GEJ cancer after two or more prior systemic therapies".
What did the company submit to support its submission?
The sponsor submitted the clinical data and study report for the single pivotal trial (ONO-4538-12/CA209316) and supportive study, CA209032, as the primary evidence to support the new indication. Population PK study reports were also submitted. This submission received a Notice of Non-Compliance (NON) on March 29, 2019. In response to the NON, the sponsor submitted additional information with respect to efficacy and safety to address the identified concerns.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of cancellation, the review of the submission was completed. Health Canada had identified some deficiencies in the data that would have to be addressed prior to market authorization. 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.
Additional information
*Proposed Brand Name:
Opdivo