INTERNATIONAL DESK — The FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) as neoadjuvant treatment, followed by Imfinzi monotherapy after surgery, for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for or have refused cisplatin-based chemotherapy. The approval, granted under Priority Review, is based on the Phase III VOLGA trial, presented at the 2026 ESMO Congress and published in The New England Journal of Medicine.
Results showed the regimen reduced the risk of disease progression, recurrence, not undergoing surgery or death by 49% (EFS HR 0.51) and cut the risk of death by 42% (OS HR 0.58) versus surgery alone. An estimated 64% of treated patients remained event-free at two years, compared with 45% in the comparator arm, while 78% were alive at two years versus 69%. Dr Jonathan Rosenberg of Memorial Sloan Kettering Cancer Centre said: “This approval brings the first perioperative immunotherapy regimen where enfortumab vedotin is administered only in the neoadjuvant setting.
The VOLGA regimen has the potential to become a new standard of care in this curative-intent setting.” About one in four bladder cancer patients has muscle-invasive disease, and up to half are ineligible for cisplatin due to impaired kidney function or comorbidities. Historically, these patients faced radical cystectomy alone, with high recurrence rates. The safety profile was consistent with the individual medicines, with Grade ¾ adverse events in 64% of treated patients versus 44% in the comparator arm.