Global biopharmaceutical company AstraZeneca (LSE/STO/NASDAQ:AZN) announced on Friday that it has received European Union approval for Imfinzi (durvalumab) as the first and only perioperative immunotherapy for adult patients with resectable muscle-invasive bladder cancer (MIBC).

The treatment combines Imfinzi with gemcitabine and cisplatin before surgery, followed by Imfinzi monotherapy after radical cystectomy.

The approval is based on results from the NIAGARA Phase III trial, which demonstrated a 32% reduction in the risk of disease progression, recurrence, or death compared to standard neoadjuvant chemotherapy alone. Overall survival data also showed a 25% reduction in the risk of death, with 82.2% of patients on the Imfinzi regimen alive at two years versus 75.2% in the comparator arm.

Imfinzi was well tolerated in both neoadjuvant and adjuvant settings, with no new safety signals observed. The European Society for Medical Oncology awarded the regimen its highest possible clinical benefit rating in curative settings.

Bladder cancer is the ninth most common cancer worldwide, and approximately half of MIBC patients experience recurrence after surgery. The NIAGARA trial, the largest of its kind in this setting, involved over 1,000 patients across 22 countries.

Imfinzi is already approved in the United States and several other countries for this indication, with additional regulatory reviews ongoing globally.