6 August 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab) for the treatment of patients with resectable muscle invasive bladder cancer in combination with gemcitabine and cisplatin as neo-adjuvant treatment, followed by adjuvant Imfinzi monotherapy treatment after radical cystectomy.
The approval is based on results from the NIAGARA Phase III trial, which were published in The New England Journal of Medicine.