AstraZeneca's immunotherapy drug, Imfinzi (durvalumab), is making strides in the treatment of muscle-invasive bladder cancer (MIBC). The company has recently submitted an application to the European Medicines Agency (EMA) for its use based on positive results from the NIAGARA Phase III trial. This trial demonstrated a significant 32% reduction in the risk of disease progression or recurrence and a 25% reduction in the risk of death compared to standard mechanisms, as reported by Europawire.

In the United States, Imfinzi has already received approval from the U.S. Food and Drug Administration (FDA) as of March 2025. The FDA approved its use in combination with gemcitabine and cisplatin as a neoadjuvant treatment, followed by Imfinzi monotherapy, for adults with MIBC undergoing radical cystectomy. The approval was also based on the outcomes from the NIAGARA trial, according to Biospace.

Efforts to expand the use of Imfinzi in treating MIBC are ongoing globally, with regulatory applications currently under review in several countries, including Japan and Brazil. These developments emphasize AstraZeneca's strategy to establish Imfinzi as a primary treatment option worldwide for this aggressive cancer type.