FDA-Approved Options for High-Risk BCG-Unresponsive NMIBC

EP: 1.Assessing Risk in NMIBC: A Foundation for Therapy

EP: 2.From Papillary to CIS: Tailoring NMIBC Treatment

EP: 3.Defining and Managing BCG-Unresponsive NMIBC

EP: 4.NMIBC Maintenance Therapy: Timing, Dosing, and Follow-Up

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EP: 5.FDA-Approved Options for High-Risk BCG-Unresponsive NMIBC

EP: 6.An Overview Of Pembrolizumab for High-Risk BCG Unresponsive NMIBC

EP: 7.An Overview of Nogapendekin Alfa Inbakicept for High-Risk, BCG-Unresponsive NMIBC

EP: 8.Real-World Outcomes With Nadofaragene in BCG-Unresponsive NMIBC

EP: 9.Exploring Nadofaragene Firadenovec: Ongoing Trials and Study Designs

EP: 10.Topline Results From Recent NMIBC Trials

EP: 11.Overcoming Challenges in Accessing New Therapies for NMIBC

EP: 12.Navigating Access Barriers: Resources to Support New Treatment Access

EP: 13.Reflecting on NMIBC Progress: Highlights From AUA 2025 and What’s Ahead

Physician Summary:

Three recently FDA-approved agents for the treatment of high-risk, BCG-unresponsive NMIBC provide alternative options for patients who do not respond to standard BCG therapy. Here is a brief overview of each therapy, their mechanisms of action, and methods of administration:

1. Nadofaragene firadenovec (Adstiladrin)

• Mechanism of Action: Nadofaragene firadenovec is a gene therapy that delivers a modified adenovirus encoding the gene for interferon-alfa 2b directly into the bladder. This induces a local immune response that targets cancer cells, particularly for carcinoma in situ and papillary tumors.

• Administration: Administered via intravesical instillation, typically once every 3 months. The viral vector is delivered into the bladder through a catheter, and the therapy works by utilizing the patient’s own immune system to recognize and destroy tumor cells.

1. Other Recently Approved Agents (eg, gemcitabine and docetaxel)

• Mechanism of Action: These are chemotherapy agents. Gemcitabine works by inhibiting DNA synthesis in rapidly dividing cancer cells, while docetaxel disrupts microtubule function to prevent cancer cell division.

• Administration: Both are administered via intravesical instillation, though schedules and frequency may vary. Gemcitabine is usually given once a week, while docetaxel is often given in a similar regimen, depending on the patient’s specific clinical needs.

These novel therapies provide crucial options for patients with BCG-unresponsive NMIBC, each utilizing different mechanisms—immune modulation via gene therapy (nadofaragene firadenovec) and direct cytotoxic effects (gemcitabine and docetaxel).