AstraZeneca PLC has secured a priority review in the US for its Imfinzi immunotherapy combined with enfortumab vedotin in patients with muscle-invasive bladder cancer.
The Food and Drug Administration (FDA) reserves priority review for medicines that could offer significant improvements over existing treatments.
A decision is expected in the fourth quarter of 2026.
The application covers patients who cannot take, or have declined, cisplatin, the chemotherapy drug at the core of standard treatment.
Up to half of patients with this form of the disease are ineligible for cisplatin because of poor kidney function or other health problems.
For them, the usual option has been radical cystectomy, surgery to remove the bladder, though around 50% see their cancer return.
The filing rests on the VOLGA Phase III trial, which enrolled 695 patients across 25 countries.
Patients received Imfinzi and enfortumab vedotin before surgery, then Imfinzi alone afterwards, an approach known as perioperative treatment.
The combination delivered statistically significant and clinically meaningful gains in overall survival compared with surgery, with or without approved follow-up treatment.
It also improved event-free survival, the time patients live without their cancer returning or worsening.
No new safety signals emerged, and the full data will be presented at a forthcoming medical meeting.
Susan Galbraith, AstraZeneca's head of oncology research and development, said the review reinforced Imfinzi's potential as the immunotherapy backbone in the disease.
"If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery," she added.
Regulators in the EU, Japan and several other countries are also reviewing the data.
Muscle-invasive disease, where the tumour grows into the bladder's muscle wall, accounts for about one in four bladder cancer cases.
Around 15,000 patients will be treated for it in the US this year.
Imfinzi is already approved in more than 50 countries for cisplatin-eligible patients, based on the NIAGARA trial.
More than 470,000 patients have received the drug since its first approval in 2017.
