Recent Advances in Intravesical Chemotherapy: Insights into the FDA-Approved Gemcitabine-Releasing TAR-200 System for Bladder Cancer Management.

The FDA approval of the gemcitabine intravesical system (Inlexzo/TAR-200) marks a breakthrough for BCG-unresponsive NMIBC with CIS. This novel drug-device combination enables sustained intravesical chemotherapy, achieving high complete response rates with acceptable safety. It represents a paradigm shift in bladder-sparing therapy, though long-term outcomes and accessibility remain critical considerations.