{"id":12659,"date":"2026-04-08T05:00:11","date_gmt":"2026-04-08T09:00:11","guid":{"rendered":"https:\/\/www.med.unc.edu\/urology\/?p=12659"},"modified":"2026-04-01T11:37:02","modified_gmt":"2026-04-01T15:37:02","slug":"ahead-of-the-curve-from-clinical-trials-to-clinical-practice-expanding-bladder-cancer-treatment-options-at-unc-urology","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/urology\/ahead-of-the-curve-from-clinical-trials-to-clinical-practice-expanding-bladder-cancer-treatment-options-at-unc-urology\/","title":{"rendered":"Ahead of the Curve: From Clinical Trials to Clinical Practice \u2013 Expanding Bladder Cancer Treatment Options at UNC Urology"},"content":{"rendered":"

\"aheadBladder cancer is often not a single moment in a patient\u2019s life, but a condition managed over time \u2013 marked by surveillance, possible recurrence, and evolving treatment decisions. For many patients with non\u2013muscle-invasive bladder cancer (NMIBC), Bacillus Calmette-Gu\u00e9rin (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.<\/p>\n

At UNC Urology, that landscape is changing.<\/p>\n

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 \u2013 highlighted in earlier \u201cAhead of the Curve\u201d features exploring combination immunotherapy approaches and novel clinical trial pathways<\/a> \u2013 UNC has helped evaluate therapies that are now reshaping the standard of care.<\/p>\n

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.<\/p>\n

New FDA-Approved Therapies Available at UNC Urology<\/h2>\n

For patients with NMIBC \u2013 particularly those whose disease has not responded to BCG \u2013 the following therapies represent important additions to the spectrum of bladder-sparing options.<\/p>\n

Adstiladrin\u00ae (nadofaragene firadenovec)*<\/sup><\/h3>\n

Adstiladrin is an intravesical gene therapy designed to stimulate the body\u2019s immune response directly within the bladder. Administered once every three months, it works locally \u2013 targeting cancer cells while minimizing systemic exposure.<\/p>\n

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.<\/p>\n

Anktiva\u00ae (nogapendekin alfa inbakicept) in combination with BCG*<\/sup><\/h3>\n

Anktiva builds on the foundation of BCG therapy by enhancing the immune system\u2019s ability to recognize and attack cancer cells. As an interleukin-15 (IL-15) receptor agonist, it activates natural killer (NK) cells \u2013 key components of the body\u2019s immune defense.<\/p>\n

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.<\/p>\n

ZUSDURI\u2122 (mitomycin intravesical gel)*<\/sup><\/h3>\n

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.<\/p>\n

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.<\/p>\n

INLEXZO\u2122 (gemcitabine intravesical system)<\/h3>\n

INLEXZO utilizes a device-based delivery system to provide continuous release of gemcitabine directly into the bladder over an extended period.<\/p>\n

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.<\/p>\n

*<\/sup> – Indicates therapies that were previously available to patients through clinical trials conducted at UNC Urology prior to FDA approval.<\/div>\n

Why This Matters for Patients in North Carolina<\/h2>\n

For patients navigating bladder cancer, access to these therapies can significantly influence both treatment decisions and quality of life.<\/p>\n

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 \u2013 bringing advanced treatment closer to home for patients across North Carolina.<\/p>\n

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.<\/p>\n