July 26, 2025
On July 17, 2025, the FDA granted Priority Review to the New Drug Application for TAR‑200 (gemcitabine-releasing intravesical system) for BCG-unresponsive high-risk non–muscle-invasive bladder cancer. This follows strong SunRISe-1 data presented at AUA 2025: 82.4% complete response rate,12-month durability of 52.9%, and low discontinuation due to toxicity. TAR‑200is designed for outpatient delivery with localized exposure, improving convenience and safety.
Citation: https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-u-s-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-bladder-cancer
Implication: Priority Review accelerates TAR‑200’s regulatory path and underscores its potential as a non-surgical bladder-sparing alternative. Messaging should highlight durability and local delivery versus systemic therapies.