The End of the Chemo Era for Bladder Cancer?

Regulators grant priority review to an antibody-drug and immunotherapy regimen intended to reduce recurrence in surgical patients

23 Apr 2026

The US Food and Drug Administration has granted priority review to a supplemental biologics license application for the combination of enfortumab vedotin and pembrolizumab. The treatment is intended for patients with muscle-invasive bladder cancer both before and after surgical intervention. The agency has set a target action date of August 17, 2026.

The submission is supported by data from the Phase 3 EV-304 clinical trial. Results indicated that the combination therapy reduced the risk of disease recurrence, progression, or death by 47 per cent when compared to standard chemotherapy. Additionally, the risk of death was reduced by 35 per cent among participants.

Currently, more than half of patients diagnosed with this form of cancer experience a return of the disease despite undergoing successful surgery. "This move could establish a new standard of care for patients regardless of their eligibility for traditional chemotherapy," the application noted.

The regimen utilizes an antibody-drug conjugate to target the Nectin-4 protein while employing immunotherapy to stimulate a broader immune response. Trial data showed that 55 per cent of participants had no detectable disease at the time of their operation.

Medical professionals continue to monitor safety profiles associated with the treatment. Reported side effects include skin reactions and peripheral neuropathy, which require clinical oversight during the perioperative period.

If approved, the therapy would shift advanced treatments into earlier stages of the disease. This transition reflects a broader institutional move toward precision medicine in oncology. The decision in August will determine if the regimen becomes the primary clinical option for surgeons and oncologists.