How is this drug name pronounced?
Nadofaragene firadenovec: NA-doh-FAR-uh-jeen FIR-uh-DEH-noh-vek
What cancer(s) does this drug treat?
Adstiladrin is approved for:
- Patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), that does not respond to Bacillus Calmette-Guerin (BCG) treatment.
Limitations of use:
Age: The safety and efficacy of Adstiladrin in patients under 18 years of age have not been established.
Exclusions: Adstiladrin should not be administered to patients whose immune system has a reduced ability (immunocompromised) or no ability (immunodeficient) to fight off infections or disease.
Pregnancy/Breastfeeding: Adstiladrin may cause harm to a fetus, and is not recommended for use during pregnancy. Women should use contraception during treatment with Adstiladrin and for at least 6 months after the last dose of Adstiladrin. Men should use contraception during treatment with Adstiladrin and for at least 3 months after the last dose of Adstiladrin. The risks associated with Adstiladrin during breastfeeding are not known and cannot be ruled out. Due to the potential for adverse reactions in the breastfed child, the benefits of breastfeeding and the patient’s need for treatment should be weighed accordingly before moving forward with treatment with Adstiladrin.
What type of immunotherapy is this?
How does this drug work?
- Target: Type I interferon receptors (IFNAR1/2)
Adstiladrin is a gene therapy that stimulates cells of the bladder to produce high levels of interferon-alfa 2b (IFNα2b) over a period of time. Interferons, such as IFNα2b, are an important part of “cell signaling”, which is when different cells in the body “talk” to one another using chemical signals. IFNα2b binds to type I interferon receptors, found on the surface of many different types of cells, including immune cells and cancer cells. The exact mechanism by which IFNα2b helps fight bladder cancer is not known. It is thought to activate one or more parts of the immune system in its fight against cancerous cells, to directly induce death in cancer cells, or to work in both ways. Adstiladrin delivers the gene with the instructions for making IFNα2b into the cells of the bladder via a harmless (non-pathogenic) virus.
How is this drug given to the patient?
Before each dose of Adstiladrin, patients receive a medication (an anticholinergic) to suppress the urge to urinate.
Adstiladrin is administered directly into the bladder through a urinary catheter. Every 3 months, 75 ml (about 2 and a half ounces) of Adltiladrin are administered into the bladder and left in for about 1 hour. During this time, the patient may be repositioned every 15 minutes to maximize the exposure of the entire bladder surface to Adstiladrin.
After each treatment, patients should add half a cup of bleach to the toilet bowl before they urinate, and wait 15 minutes before they flush the toilet, to break down any Adstiladrin that may be excreted. These steps should be repeated for every bathroom use during the first two days after treatment.
What are the observed clinical results?
It is important to keep in mind that each patient’s actual outcome is individual and may be different from the results found in the clinical studies.
In a clinical trial, 98 patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), that did not respond to Bacillus Calmette-Guerin (BCG) treatment, and for whom any amount of tumor that could be removed by surgery was removed, were treated with Aldstiladrin every 3 months for up to one year. 51% of patients saw their tumor completely disappear, and 46% of these patients continued to respond to treatment for more than 1 year.
What are the side effects?
The most common side effects of Adstiladrin include abnormal blood test results (including increased blood glucose and triglyceride levels), fatigue, chills, fever, cramping of the bladder, blood in urine, urinary discharge, urgency to urinate, and painful urination.
Delaying surgery to remove all or part of the bladder increases the risk of the bladder cancer spreading into the thick muscle in the bladder wall and to other parts of the body. Patients with carcinoma in situ (CIS) who do not respond to treatment with Adstiladrin within 3 months should be considered for surgical removal of all or part of the bladder.
Patients should report any symptoms to their healthcare provider, who can then initiate actions to limit or reverse the side effects. For a more complete list of possible side effects, see the full prescribing information.
Links to drug websites
- US: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin?utm_source=salesforce-marketing-cloud&utm_medium=email&utm_campaign=SPGA+-+FDA+Alert+-+12.19.2022&utm_term=View+full+prescribing+information+for+Adstiladrin
- Europe: N/A
Last updated on December 20, 2022