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FDA Approves Imfinzi Combination for Bladder Cancer

lite News Desk 2 min read

AstraZeneca’s durvalumab, sold as Imfinzi, received FDA approval on November 13, 2026, for a treatment course combining it with enfortumab vedotin-ejfv before surgery and continuing durvalumab alone after radical cystectomy. According to the FDA, eligibility covers adults whose bladder cancer is muscle-invasive and who cannot receive cisplatin-based chemotherapy or have declined it.

AstraZeneca defines muscle-invasive disease as a tumor extending into the bladder’s muscle wall. The company said radical cystectomy alone historically served as standard treatment for patients unable to receive cisplatin-based chemotherapy.

Under the FDA’s recommended schedule, patients receive both drugs over three cycles before surgery, with enfortumab administered on each cycle’s first and eighth days. After surgery, durvalumab is given at four-week intervals for a maximum of nine cycles. The agency specifies earlier discontinuation if cancer recurs, toxicity becomes unacceptable, or progression makes definitive surgery impossible.

The FDA described VOLGA as an open-label, randomized study involving 695 patients eligible for bladder-removal surgery who either could not receive cisplatin-based chemotherapy or had refused it. Assignment was among three groups: the durvalumab-enfortumab course surrounding surgery, another investigational drug combination, and surgery alone.

Published VOLGA findings put the 24-month estimate for event-free survival at 63.5% in the durvalumab-enfortumab group, compared with 45.1% among participants receiving surgery alone. For an event or death, the hazard ratio was 0.51. According to the FDA’s analysis, the surgery-only group had median event-free survival of 12.1 months, while the combination group had not reached that median.

That endpoint covers more than cancer returning. AstraZeneca’s trial account includes disease progression, recurrence following surgery, death, and failure to reach surgery under specified circumstances in its definition of an event.

For overall survival, the published estimates at 24 months were 78.4% for the drug-combination group and 69.4% for the surgery-only group, with a death hazard ratio of 0.58. Neither group had reached median overall survival when the FDA conducted its analysis, according to the agency.

The FDA’s safety information identifies durvalumab risks involving immune-mediated and infusion-related reactions, complications associated with allogeneic stem-cell transplantation, and embryo-fetal toxicity. Its information also lists common adverse reactions and laboratory abnormalities associated with the durvalumab-enfortumab combination.

* This article is based on publicly available information at the time of writing.

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