<p>The FDA approval of Inlexzo (gemcitabine intravesical system, formerly TAR-200) for BCG-refractory non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ is a milestone achievement in bladder-sparing therapy. Outcomes from the SunRISe-1 trial showed an outstanding 3-month complete response rate of 82%, and sustainability in more than half of responders at 12 months. Yet enthusiasm must be balanced with significant cautions: lack of comparator arm, immature long-term survival data, and practical issues with indwelling intravesical delivery, risk of infection, and access in low-resource environments. While Inlexzo is promising in a population where alternatives are scarce, its place must be clarified by longer-term follow-up, randomized comparisons versus systemic and intravesical therapies, and real-world experience. Prior to that, clinicians must utilize open counseling and shared decision-making.</p>