Perioperative Immunotherapy Regimen for Bladder Cancer
The FDA has approved the Immunotherapy durvalumab in combination with chemotherapy for certain patients with resectable bladder cancer.
The U.S. Food and Drug Administration (FDA) has approved durvalumab (Imfinzi) in combination with chemotherapy before surgery and as monotherapy after surgery for the treatment of adult patients with resectable muscle-invasive bladder cancer that has not been previously treated with systemic therapy.
Durvalumab is an immune checkpoint inhibitor, a type of immunotherapy that can improve the immune system’s ability to recognize and destroy cancer cells, and previously received an accelerated approval for certain patients with previously treated advanced bladder cancer.
The latest approval was based on results from the randomized, open-label, phase III NIAGARA clinical trial that enrolled 1,063 patients with resectable bladder cancer who had not received prior systemic therapy. Patients were randomly assigned (1:1) to receive durvalumab and chemotherapy prior to surgery and then durvalumab after, or chemotherapy followed by surgery.
At 24 months follow-up, perioperative durvalumab plus presurgical chemotherapy reduced the risk of an event—defined as disease progression that precluded surgery, relapse, not undergoing surgery, or death—by 32% and reduced the risk of death by 25% versus chemotherapy alone. The median time to an event was not reached in the combination arm, whereas at least half of tumors treated with chemotherapy alone had experienced an event at 46.1 months.
The recommended schedule for durvalumab is every three weeks with chemotherapy before surgery, and every four weeks after surgery. The recommended dose for durvalumab is 1,500 mg in patients weighing 30 kg or more, and 20 mg/kg in those weighing less than 30 kg. Treatment should be stopped if the tumor becomes inoperable or recurs, in the event of unacceptable toxicity, or at a maximum of eight cycles after surgery.
Bladder cancer is a type of cancer that develops in the lining of the bladder. Roughly 25% of bladder cancer cases invade the bladder muscle wall and are classified as muscle-invasive bladder cancer. According to federal statistics, it was estimated that 84,870 individuals would be diagnosed with bladder cancer and 17,420 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on March 28, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.