AstraZeneca Gains European Approval for Perioperative Immunotherapy for MIBC
With the durvalumab-based perioperative regimen, MIBC patients have a new treatment option that has been proven to provide statistically significant and clinically meaningful improvement in survival rates.
The European Commission has approved AstraZeneca’s durvalumab (Imfinzi) as the first and only perioperative immunotherapy for muscle-invasive bladder cancer (MIBC), the company revealed in a July 4, 2025 press release (1). This regulatory decision has been based on the results from the NIAGARA Phase III clinical trial and was preceded by a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
Current treatment options for MIBC include chemotherapy, radical cystectomy (surgical removal of the bladder), and radical radiotherapy; however, while bladder removal is associated with the best chance of cure for MIBC patients, up to 50% of them will still experience disease recurrence (2). As a result of the poor outcomes and significant side effects associated with the current treatment options, novel approaches to prevent disease recurrence after surgery are critically needed.
Durvalumab is a human monoclonal antibody that works by binding to the PD-L1 protein and blocking its interaction with PD-1 and CD-80 proteins, which offsets the tumor’s immune-evading tactics and releases the inhibition of immune responses. The EC approved regimen is for durvalumab to be used in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by durvalumab as monotherapy adjuvant treatment after radical cystectomy, as set out in the NIAGARA trial.
“The durvalumab-based perioperative regimen is an important new treatment option for patients in Europe with muscle-invasive bladder cancer, as currently nearly half experience disease recurrence despite treatment with neoadjuvant chemotherapy and surgery to remove the bladder,” said Dr. Michiel Van der Heijden, medical oncologist and Group Leader at the Netherlands Cancer Institute, and investigator in the NIAGARA trial, in the company press release (1). “The NIAGARA results showed how this regimen reduced the risk of recurrence by nearly a third and significantly extended survival, underscoring its potential to transform clinical practice in this curative-intent setting.”
Results from the NIAGARA Phase III clinical trial — a randomized, open-label, multi-center trial — demonstrated statistically significant and clinically meaningful improvement in event-free survival and overall survival in patients with MIBC when compared with neoadjuvant chemotherapy (3). Additionally, the treatment was found to be well-tolerated with no new safety signals observed in the neoadjuvant and adjuvant settings.
“Imfinzi is poised to transform the standard of care for muscle-invasive bladder cancer in Europe as the first and only perioperative immunotherapy for these patients,” added Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, in the press release (1). “In the NIAGARA Phase III trial, more than 80% of patients were still alive two years after treatment with the Imfinzi regimen, setting a new survival benchmark for a disease that has seen few treatment advances in decades.”
Durvalumab is already approved in the U.S. and other countries for this indication. Further regulatory reviews are underway in Japan and several other countries.
References
AstraZeneca. Imfinzi Approved in the E.U. as First and Only Perioperative Immunotherapy for Muscle-Invasive Bladder Cancer. Press Release, July 4, 2025.
NICE. Bladder Cancer: Diagnosis and Management. Guideline NG2, Feb. 25, 2015.
AstraZeneca. Imfinzi Perioperative Regimen Reduced the Risk of Recurrence by 32% and the Risk of Death by 25% vs. Neoadjuvant Chemotherapy Alone in Muscle-Invasive Bladder Cancer in the NIAGARA Phase III Trial. Press Release, Sept. 15, 2025.