Adstiladrin Earns FDA-Approval as New Gene Therapy for Bladder Cancer

At the close of 2022, the FDA approved Adstiladrin (nadofaragene firadenovec-vncg) as a gene therapy treatment for patients whose cancer is at high risk of progressing by invading muscle tissue and spreading throughout the body. Addressing an area of critical need, Adstiladrin is administered once every three months into the bladder via a urinary catheter to treat bladder cancer that does not respond to an immunotherapy that’s commonly used as a first-line treatment to treat the cancer in its early stages.

According to the FDA, bladder cancer, one of the more common forms of cancer, is a disease in which malignant (cancer) cells form a tumor in the tissues of the bladder. These abnormal cells can invade and destroy normal body tissue. Over time, the abnormal cells can also metastasize (spread) through the body.

Most newly diagnosed bladder cancers (75% to 80%) are classified as NMIBC – a type of cancer that has grown through the lining of the bladder but hasn’t yet invaded the muscle layer. This type of cancer is associated with high rates of recurrence (between 30 to 80%) and the risk of progression to invasive and metastatic cancer.  

To learn more about Adstiladrin, click here.