Journal: World journal of urology
The FDA approval of Inlexzo (gemcitabine intravesical system) marks a significant advance in bladder-sparing treatment for BCG-refractory non-muscle invasive bladder cancer with carcinoma in situ.
The SunRISe-1 trial showed:
- 82% complete response rate at 3 months
- More than half of responders maintained their response at 12 months
However, caution is needed due to:
- The absence of a comparator arm
- Limited long-term survival data
- Practical challenges including intravesical delivery, infection risk, and accessibility in resource-limited settings
While Inlexzo offers a promising option where few exist, its definitive role requires:
- Longer-term follow-up
- Randomized trials against existing therapies
- Real-world validation
Clinicians should engage in thorough counseling and shared decision-making with patients before use.