Pre-Approval Access to TAR-200 for Treating High-Risk Non-Muscle Invasive Bladder Cancer

Inclusion Criteria

• You have tried all other suitable treatments and cannot join a clinical trial.
• You have been diagnosed with high-risk non-muscle invasive bladder cancer that has come back or persisted, even after receiving Bacillus Calmette-Guérin (BCG) therapy within the last year.
• Any visible bladder tumors must be removed before starting treatment.
• You are not eligible for or have chosen not to have surgery to remove the bladder (Radical Cystectomy).
• You are in relatively good health, with an ECOG performance status of 0, 1, or 2, meaning you are fully active or have some limitations but can still care for yourself.

Exclusion Criteria

• You have bladder cancer that has spread into the muscle, is locally advanced, cannot be removed, or has spread to other parts of the body.
• You have any bladder or urethral conditions that might make it unsafe to use TAR-200.
• You have tumors in the prostatic urethra (in men).
• You have had a bladder perforation during a diagnostic procedure.
• You have a history of producing more than 4000 milliliters of urine in a day.
• You have other active cancers that have progressed or required a change in treatment in the last two years, other than HR-NMIBC.