FDA approves Imfinzi with enfortumab for bladder cancer before and after surgery

Key Facts

The U.S. Food and Drug Administration on November 13, 2026, approved durvalumab, marketed as Imfinzi, with enfortumab vedotin-ejfv before surgery, followed by durvalumab alone after radical cystectomy. The decision covers adults with muscle-invasive bladder cancer who are ineligible for or declined cisplatin-based treatment, according to the FDA. The regimen adds a treatment option before and after surgery for this group of patients. The efficacy assessment was based on the randomized, open-label VOLGA trial, which enrolled 695 patients who were candidates for cystectomy and were ineligible for or declined cisplatin-based treatment. The trial randomly assigned participants to three treatment arms.

In the arm testing the combination, patients received 3 cycles of Imfinzi and enfortumab vedotin before surgery, followed by 9 cycles of Imfinzi alone, according to AstraZeneca. VOLGA results showed a 49% reduction in the composite risk of disease progression or recurrence, failure to undergo surgery or death, compared with the control arm. Median event-free survival had not yet been estimated in the combination arm, versus 12.1 months in the control arm. The hazard ratio was 0.51, according to the company. The FDA describes the comparison as being against cystectomy alone, while the results were reported in a planned interim analysis of the trial.

Overall survival data showed a 42% reduction in the risk of death with the combination regimen compared with the control arm, according to AstraZeneca. Median overall survival had not yet been estimated in either arm, and the hazard ratio was 0.58. The company estimated that 78% of patients who received Imfinzi were alive after 2 years, versus 69% in the control arm. The FDA also said the trial showed a statistically significant improvement in overall survival compared with surgery alone. Median overall survival was not reported in either arm at the time of the analysis.

Thomas Powles, the international coordinating investigator for the VOLGA trial, said the cancer returns in about half of patients despite bladder removal surgery. He described the perioperative regimen as combining durvalumab with enfortumab vedotin before surgery, and said the reduction in the risk of death was 42%. He also described the safety profile as "manageable," according to an AstraZeneca statement. The FDA says common adverse reactions occurring in more than 20% of patients include rash, fatigue, nausea and peripheral neuropathy. Durvalumab's label includes warnings about immune-mediated reactions associated with treatment.

The decision comes within a treatment pathway that includes other standard options for patients with muscle-invasive bladder cancer whose treatment aims to cure. The National Cancer Institute lists cisplatin-based combination chemotherapy before radical cystectomy, or radiation therapy given concurrently with chemotherapy, among those options. The approval is significant for patients who are ineligible for or decline cisplatin, the group specified in the FDA decision. The FDA approved a different regimen on March 28, 2025, combining durvalumab with gemcitabine and cisplatin before surgery, followed by durvalumab afterward. The assessment of that regimen was based on the NIAGARA trial, which included 1,063 patients.

The current approval came six weeks before the FDA's target action date, after the application received priority review, according to the agency. AstraZeneca announced on September 25, 2026, that the application had been granted priority review, with a regulatory decision expected during the fourth quarter of the year. The company said regulatory applications for the regimen were under review in the European Union, Japan and other countries. In trading on November 13, AstraZeneca shares closed at $184.45, according to EL7 data. Reliable open data to verify the session's opening, high or low prices was not available.