The U.S. Food and Drug Administration has updated the label for nadofaragene firadenovec-vncg, a gene therapy used to treat high-risk non–muscle-invasive bladder cancer that no longer responds to standard BCG treatment.
The update introduces a faster thawing process using a warm water bath, cutting preparation time to about 25 minutes. This makes it easier for clinics to prepare the treatment and deliver it more efficiently.
This therapy works by using a modified virus to deliver a cancer-fighting gene into the bladder. The cells then produce interferon, a protein that helps attack cancer locally. It is given through a catheter once every three months, which means fewer hospital visits compared to other treatments.
The therapy was first approved in 2022 after a study showed that 51% of patients had a complete response, and nearly half of those maintained the response for at least one year. The average response lasted about 9.7 months.
For patients who do not respond to BCG, treatment options are often limited to bladder removal surgery. This gene therapy offers a bladder-sparing alternative that is now quicker and easier to use in clinical practice.