Posted by Michael Wonder on 07 Nov 2017
Health Canada approves Imfinzi (durvalumab) for previously treated patients with advanced bladder cancer
6 November 2017 - Approval granted based on promising tumour response rate and duration of response.
AstraZeneca Canada today announced that Health Canada has approved Imfinzi (durvalumab) for the treatment of advanced bladder cancer in previously treated patients. Imfinzi, an immuno-oncology therapy that activates the body's own immune system to fight cancer cells, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neo-adjuvant) or after (adjuvant) surgery.
Reviewed under Health Canada's accelerated approval framework, Imfinzi has been granted Notice of Compliance with Conditions based on tumour response rate and durability of response.
