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Adstiladrin® (nadofaragene firadenovec-vncg)

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By Editorial Team

2 min read

Reviewed by: HU Medical Review Board | Last reviewed: January 2023

Adstiladrin® (nadofaragene firadenovec-vncg) is a type of gene therapy approved to treat adults with certain forms of high-risk NMIBC that Bacillus Calmette-Guerin (BCG) therapy is not working to treat. NMIBC stands for non-muscle invasive bladder cancer. It is one of the most common forms of bladder cancer at the time of diagnosis.1

Currently, initial treatment for NMIBC usually involves BCG therapy. But BCG does not work for everyone. Adstiladrin is the first gene therapy approved by the US Food and Drug Administration (FDA) to treat high-risk NMIBC. It has shown promise in treating NMIBC that does not respond to BCG therapy.1-3

In the Adstiladrin clinical study, slightly more than half of people who used this gene therapy for their BCG-unresponsive NMIBC reached the point of having no clinical signs of cancer. And almost half of that group stayed free of cancer signs for at least a year.1,2

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What are the ingredients in Adstiladrin?

Adstiladrin contains a virus that is used to carry a gene to the cells that line the inside of the bladder.3

How does Adstiladrin work?

Adstiladrin uses a carrier virus called an adenovirus. The medicine is injected into the bladder for a period of time. There, it latches onto cells and introduces the gene into the cells.1,2,4

Once the gene is inside the bladder cells, the cells start making a protein called interferon alfa-2b. This protein then acts like a big flashing sign to the immune system to target the cancer cells. This means that once the gene therapy is injected, your body’s immune system can respond to get rid of the cancer cells.5

What are the possible side effects?

The most common side effects of Adstiladrin include:1

  • Bladder discharge (from where the medicine is given)
  • Fatigue
  • Bladder spasms or an urgent need to urinate
  • Blood in the urine
  • Chills
  • Fever
  • Painful urination

These are not all the possible side effects of Adstiladrin. Talk to your doctor about what to expect when taking this drug. You also should call your doctor if you have any changes that concern you when taking Adstiladrin.

Other things to know

Adstiladrin is approved to be given to people with certain forms of BCG-unresponsive NMIBC. Being unresponsive to BCG can mean several things, including:2

  • You have high-grade tumors even after 6 months of BCG treatment.
  • You have tried at least 5 out of 6 initial BCG doses, and 2 out of 3 maintenance treatments, without response.
  • You have a recurrence of high-grade tumors within 6 months of successful BCG treatment.

If you fit these criteria and either cannot or do not want to have bladder surgery, gene therapy may be an option. Ask your doctor if your bladder cancer is considered BCG-unresponsive and what this means for your treatment options. If you have a suppressed or lowered immune system, you likely should not undergo this treatment.1-3

If you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed, talk with your doctor. Adstiladrin has not been tested on pregnant or breastfeeding people. Therefore, doctors do not know if it is safe for this population to take. It also has not been tested to find out if it affects fertility.3

Adstiladrin has not been tested in children.3

Before beginning treatment for bladder cancer, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Adstiladrin.