Bladder cancer is often not a single moment in a patient’s life, but a condition managed over time – marked by surveillance, possible recurrence, and evolving treatment decisions. For many patients with non–muscle-invasive bladder cancer (NMIBC), Bacillus Calmette-Guérin (BCG) therapy remains the standard first-line approach. But when that treatment is no longer effective, the path forward has historically narrowed, often leading to consideration of bladder removal.
At UNC Urology, that landscape is changing.
Over the past several years, the department has played an active role in national clinical trials designed to expand options for patients facing BCG-unresponsive disease. Through that work – highlighted in earlier “Ahead of the Curve” features exploring combination immunotherapy approaches and novel clinical trial pathways – UNC has helped evaluate therapies that are now reshaping the standard of care.
Today, several of those therapies have moved beyond the research setting and into clinical practice, offering new, FDA-approved options for appropriately selected patients across North Carolina.
New FDA-Approved Therapies Available at UNC Urology
For patients with NMIBC – particularly those whose disease has not responded to BCG – the following therapies represent important additions to the spectrum of bladder-sparing options.
Adstiladrin® (nadofaragene firadenovec)*
Adstiladrin is an intravesical gene therapy designed to stimulate the body’s immune response directly within the bladder. Administered once every three months, it works locally – targeting cancer cells while minimizing systemic exposure.
As a monotherapy option for patients with BCG-unresponsive disease, Adstiladrin offers a different approach to treatment, one that leverages gene delivery to activate immune pathways and potentially delay or avoid more invasive interventions.
Anktiva® (nogapendekin alfa inbakicept) in combination with BCG*
Anktiva builds on the foundation of BCG therapy by enhancing the immune system’s ability to recognize and attack cancer cells. As an interleukin-15 (IL-15) receptor agonist, it activates natural killer (NK) cells – key components of the body’s immune defense.
Previously studied in combination therapy trials in which UNC played a key role, this approach reflects a broader shift toward immunologically driven treatment strategies that aim to improve response rates while preserving the bladder.
ZUSDURI™ (mitomycin intravesical gel)*
ZUSDURI represents an evolution in how intravesical chemotherapy is delivered. Administered as a liquid, it transitions into a gel at body temperature, allowing it to remain in the bladder for extended periods.
This sustained exposure enables a more prolonged therapeutic effect compared to traditional chemotherapy instillations, offering a practical and innovative option for patients with recurrent, low-grade disease.
INLEXZO™ (gemcitabine intravesical system)
INLEXZO utilizes a device-based delivery system to provide continuous release of gemcitabine directly into the bladder over an extended period.
Designed for patients with BCG-unresponsive NMIBC, this approach allows for prolonged drug exposure without repeated instillations, reflecting a growing emphasis on both treatment effectiveness and patient convenience.
Why This Matters for Patients in North Carolina
For patients navigating bladder cancer, access to these therapies can significantly influence both treatment decisions and quality of life.
UNC Urology strives to provide early access to cutting-edge cancer treatments through clinical trials. Now, as FDA-approved options, these novel cancer therapies are available within standard clinical care – bringing advanced treatment closer to home for patients across North Carolina.
This evolution also reflects a broader shift in bladder cancer care: a growing focus on bladder preservation, individualized treatment selection, and multidisciplinary coordination between urology, medical oncology, and radiation oncology teams.
“Clinical trials are the bridge between scientific discovery and patient care. At UNC, participating in these studies allows us not only to help advance new bladder cancer therapies, but to bring those innovations directly to patients once they become part of standard clinical practice.”
Marc Bjurlin, DO, MSc, FACOS
Vice Chair of Research
Director of Clinical Trials
Associate Professor of Urology
“As the State’s hospital, it is critical that we offer the latest cancer treatment options for patients in need. In bladder cancer where the stakes are high, we can offer 2nd and 3rd line options, so patients can beat their cancer and save their bladder.”
Hung-Jui (Ray) Tan, MD, MSHPM
Chief of the Division of Urologic Oncology
Urologic Oncology Fellowship Program Director
Associate Professor of Urology
Continuing to Advance the Standard of Care
The transition of these therapies from clinical trials to clinical practice underscores a central principle of UNC Urology’s mission: ensuring that innovations in research translate directly into meaningful improvements in patient care.
By playing a key role in the studies that helped bring these therapies forward – and now offering them as part of routine care – UNC continues to contribute to the evolving standard of treatment for bladder cancer.
As new therapies emerge and additional trials open, that work continues. For patients, it means more options. For clinicians, it means more tools. And for the field of urology, it reflects steady progress toward more effective, personalized, and less invasive approaches to care.
To Learn More…
If you would like to know more about urology-related clinical trials, please contact the UNC Department of Urology at 984-974-1315.
You can learn about the broad range of clinical trials being conducted at UNC via this link to Research For Me at UNC.
If you are interested in knowing more about urologic procedures or related urologic topics, you may visit our website’s Patient Care section, or meet with a provider by contacting one of our UNC Urology clinic locations.
About Our Ahead of the Curve Series
Our “Ahead of the Curve” blog series highlights the latest and most effective treatments and techniques in patient care at UNC Urology. Urology is a complex and rapidly evolving field, with new advancements and breakthroughs constantly emerging. In this series, we will explore a range of topics related to innovative approaches to providing outstanding patient care, including advanced surgical procedures, new and improved diagnostic techniques, and innovative medical therapies. Our goal is to provide you with an overview of the excellence and innovation happening right here at UNC Urology.