Biopharmaceutical company AstraZeneca (LSE: AZN) (STO: AZN) (Nasdaq: AZN) announced on Monday that it has secured US Food and Drug Administration (FDA) approval for Imfinzi (durvalumab) as the first and only perioperative immunotherapy for adult patients with muscle-invasive bladder cancer (MIBC). The decision follows Priority Review and is based on Phase III NIAGARA trial data, which demonstrated a 32% reduction in disease recurrence risk and a 25% lower risk of death compared to neoadjuvant chemotherapy alone.

The approval covers the use of Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant therapy, followed by Imfinzi monotherapy post-surgery. The NIAGARA trial results, presented at the 2024 ESMO Congress and published in The New England Journal of Medicine, showed that 67.8% of patients on the Imfinzi regimen remained event-free at two years, compared to 59.8% in the comparator arm.

Imfinzi was well tolerated, with no new safety concerns. The regimen was added to the NCCN Clinical Practical Guidelines in Oncology as a Category 1 Recommended treatment in February 2025. Regulatory applications are under review in the EU, Japan and multiple other markets.

Bladder cancer affects over 614,000 people worldwide annually, with MIBC carrying a high recurrence rate post-surgery. AstraZeneca continues to expand its immuno-oncology portfolio, positioning Imfinzi as a cornerstone therapy across multiple cancer indications.