(UroToday.com) Most patients newly diagnosed with bladder cancer have non-muscle invasive disease (NMIBC). For patients with intermediate or high-risk NMIBC and those with carcinoma in situ (CIS), adjuvant treatment with BCG is guideline-recommended on the basis of proven benefits in disease recurrence. While BCG is efficacious, many patients eventually develop BCG-unresponsive disease. For many years, there have been very limited options for these patients. Radical cystectomy has remained the gold standard even though numerous approaches including intravesical and systemic therapies have been investigated. Nadofaragene firadenovec is a novel gene-mediated therapy that confers the human IFNα2b gene to bladder urothelium following intravesical instillation and results in prolonged, localized expression of IFNα2b. In a phase III trial, nadofaragene firadenovec treatment was associated with 53.4% of patients with CIS±Ta/T1 achieving a complete response (CR), all within the first 3 months.