Astrazeneca (AZN) said Monday that its drug Imfinzi has been approved by the Food and Drug Administration to treat adult patients with muscle-invasive bladder cancer, in combination with other treatments.
The specific therapy approved is for Imfinzi combined with gemcitabine and cisplatin as a neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy.
The approval for the drug, also called durvalumab, was granted after securing priority review and was based on results from a phase 3 trial in which it showed a 32% reduction in the risk of disease recurrence and a 25% reduction in death risk, the company said.
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