J&J gets FDA priority review for drug releasing system for bladder cancer

Johnson & Johnson (NYSE:JNJ) announced on Thursday that the U.S. FDA granted priority review for its new drug application aimed at getting marketing approval for TAR-200, a drug-releasing system for patients with a certain form of bladder cancer.

TAR-200 is designed to deliver a sustained release of the chemotherapy drug gemcitabine into the bladder of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer.

“TAR-200 represents an innovation in drug delivery that has not been seen in decades,” said Yusri Elsayed, Global Therapeutic Area Head for Oncology at J&J’s Innovative Medicine unit.

The NDA submission is backed by data from the company’s Phase 2b SunRISe-1 study, in which nearly 53% of patients who received TAR-200 remained cancer-free for at least a year after achieving complete responses.

The findings presented at the American Urological Association Annual Meeting in April 2025 further indicated that the treatment was well-tolerated among patients, with most adverse events being mild to moderate urinary symptoms.