TAR-200, an intravesical gemcitabine-releasing system, treats patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
A healthcare professional places TAR-200 into the bladder using a co-packaged urinary placement catheter. The procedure takes place in an outpatient setting in less than five minutes and requires no general anesthesia or further monitoring.
“TAR-200 represents an innovation in drug delivery that has not been seen in decades,” said J&J Innovative Medicine Global Therapeutic Area Head, Oncology, Dr. Yusri Elsayed. “The FDA priority review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer.”
The Phase 2b SunRISe-1 study demonstrated an 82.4% complete response rate. More than half (52.9%) of patients remained cancer-free at least one year or more after achieving a complete response. Johnson & Johnson noted that the majority of adverse reactions proved mild and moderate.
For adverse events, the most common (less than 10%) included pollakiuria, dysuria, urinary tract infection, micturition urgency, hematuria, cystitis noninfective, and urinary tract pain. Investigators reported no systemic adverse reactions.
