FDA approves Imfinzi with enfortumab vedotin before surgery for bladder cancer
The FDA approved an Imfinzi regimen with enfortumab vedotin for muscle-invasive bladder cancer patients who cannot receive or refuse cisplatin chemotherapy.
- published on Newsmetry
- original source published
the same feed is available to bots and dashboards through the api. connect the api →
what happened
The US Food and Drug Administration has approved AstraZeneca's Imfinzi (durvalumab) combined with enfortumab vedotin before surgery, followed by Imfinzi alone after radical cystectomy. The regimen is intended for adults with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy. The decision came under Priority Review and rests on data from the Phase III VOLGA trial, presented at the 2026 ESMO Congress and published in The New England Journal of Medicine. According to TradingView, about 16,000 patients will be treated for this cancer in the United States in 2026.
why it matters
For AstraZeneca investors, this is another expansion of its oncology portfolio. In a planned interim analysis, the risk of progression, recurrence, inability to undergo surgery or death fell by 49%, and the company reports a 42% reduction in the risk of death. The news concerns a narrow market segment and is unlikely to move broad indexes.
tags
instruments
sources
- Perioperative IMFINZI® (durvalumab) approved in the US in novel regimen with neoadjuvant enfortumab vedotin-ejfv for patients with muscle-invasive bladder cancer — TradingView, 13 November 2026 at 23:39 UTC
prepared by the newsmetry newsroom with ai assistance from the sources listed below. not investment advice.
alerts on your topics, the morning digest and the api — in your account.
get stories in real time ↗