AstraZeneca’s Imfinzi Wins EU Approval for Muscle-Invasive Bladder Cancer

AstraZeneca's cancer drug Imfinzi (durvalumab) has received European Union approval as the first and only perioperative immunotherapy for adult patients with resectable muscle-invasive bladder cancer (MIBC). This approval is based on the positive results from the NIAGARA Phase III trial, which showed a 32% reduction in the risk of disease progression, recurrence, or death, and a 25% reduction in the risk of death compared to neoadjuvant chemotherapy alone. The trial demonstrated that over 80% of patients treated with the Imfinzi regimen were still alive two years post-treatment, setting a new survival benchmark for MIBC, a disease with few recent treatment advances. Imfinzi is administered in combination with platinum chemotherapy before surgery and as monotherapy afterward to prevent cancer recurrence. AstraZeneca views bladder cancer as a significant growth opportunity for Imfinzi, which generated approximately $4.7 billion in sales last year across multiple cancer types. The approval strengthens AstraZeneca's oncology portfolio and could transform the standard of care for MIBC patients in Europe.