20 March 2018 - Health Canada's handling of the submission is perplexing.

The purpose of the supplemental new drug submission was to seek the authorisation of Opdivo (nivolumab) for use in patients with locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

The submission was supported by the CheckMate-275 trial, an open-label, single-arm phase II study of nivolumab monotherapy in patients with locally advanced or metastatic urothelial carcinoma who had prior treatment with a platinum based treatment regimen.

Health Canada identified a critical deficiency in the submission; the lack of phase III trial data. The sponsor chose to withdraw the submission on 19 January 2018 without prejudice to refiling.

This is perplexing given Health Canada approved the use of atezolizumab (Tecentriq) in April 2017 for use by patients with locally advanced or metastatic urothelial carcinoma on the basis of an open-label, single-arm phase II trial (IMvigor210).

Read Health Canada Regulatory Decision Summary for nivolumab