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A tiny pretzel-shaped device that slowly releases chemotherapy inside the bladder cleared carcinoma in situ in over 80% of patients whose BCG had failed.
Cohort 2 (TAR-200 alone): confirmed CR 82%; 51% remained in CR at 1 year; 98% of responses within 12 weeks. FDA approval of Inlexzo (gemcitabine intravesical system) on 9 September 2025 for BCG-unresponsive NMIBC with CIS. Cetrelimab added little. Phase 3 SunRISe-3 (BCG-naive) and SunRISe-4 (MIBC) ongoing.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response rate (CIS)primary | TAR-200 monotherapy | 85 | 82% | - | - | - |
| Duration of CR ≥12 months | TAR-200 monotherapy | - | 51% | - | - | - |
Shares Gemcitabine intravesical system (TAR-200), Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Johnson & Johnson, Bladder & urothelial cancer.
Shares Andrea Necchi, Johnson & Johnson, Bladder & urothelial cancer.
Shares BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants, Bladder & urothelial cancer.
Shares BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Bladder & urothelial cancer.
Shares Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Bladder & urothelial cancer.
Shares BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Bladder & urothelial cancer.