TAR-200 (gemcitabine intravesical releasing system) — Investigational Agent
Other · Phase 3 · Johnson & Johnson (Janssen)
Mechanism of Action
TAR-200 is an intravesical, silicone-based osmotic drug-releasing system (the "pretzel") placed into the bladder that provides sustained, controlled local release of gemcitabine over approximately three weeks. Gemcitabine, a nucleoside analog, is incorporated into DNA and inhibits ribonucleotide reductase, causing chain termination and apoptosis of dividing urothelial tumor cells. Continuous local exposure maintains cytotoxic drug concentrations far longer than conventional intravesical instillations while minimizing systemic absorption and toxicity. This delivery approach aims to improve…
Investigational Indications
- BCG-unresponsive high-risk non-muscle invasive bladder cancer (carcinoma in situ)
- BCG-naive high-risk NMIBC
- Muscle-invasive bladder cancer (bladder preservation)