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A small pretzel-shaped device that slowly releases gemcitabine inside the bladder cleared carcinoma in situ in about four out of five patients whose cancer had stopped responding to BCG, offering an alternative to bladder removal.
Open-label phase 2b trial of patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer with carcinoma in situ, who declined or were unfit for radical cystectomy. Cohort 2 tested TAR-200 monotherapy, an intravesical drug-releasing system placed cystoscopically every three weeks then every twelve weeks for up to two years. Primary endpoint was complete response rate.
The complete response rate was about 84%, with most responses durable beyond a year and a low rate of serious adverse events, mostly urinary symptoms. It led to FDA approval in 2025, the first intravesical drug-releasing system and a rare new option for a group whose only curative alternative is cystectomy.
Patients with high-risk bladder cancer confined to the lining whose disease has not responded to BCG now have a bladder-sparing option that clears the cancer in most cases, delivered through a simple outpatient procedure. It may allow many to avoid or defer cystectomy, a life-changing operation. Whether responses translate into avoided progression and cystectomy over the long term, and how it compares with cystectomy on survival, remain to be shown.
Shares Andrea Necchi, Johnson & Johnson, Bladder & urothelial cancer.
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