FDA Grants Priority Review to TAR-200 in BCG-Unresponsive High-Risk NMIBC

FDA Grants Priority Review to TAR-200 for Bladder Cancer Subset

FDA grants priority review to TAR-200, which demonstrated an 82% complete response in high-risk bladder cancer unresponsive to Bacillus Calmette-Guérin.

Johnson & Johnson gets FDA priority nod for drug delivery system

The TAR-200 implant. [Image courtesy of J&J]Johnson & Johnson (NYSE:JNJ) announced today that the FDA granted priority review to a new drug application (NDA) for its TAR-200. 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 T…

FDA Grants Priority Review to TAR-200 in BCG-Unresponsive High-Risk NMIBC

Phase 2b SunRISe-1 trial findings supported the FDA to grant priority review to TAR-200 in BCG-unresponsive high-risk NMIBC with carcinoma in situ.

TAR-200 Granted Priority Review for Non–Muscle-Invasive Bladder Cancer

Based on durable response data, TAR-200 has been given priority review for the treatment of patients with high-risk non–muscle-invasive bladder cancer.

Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer - Life Sciences British Columbia

New Drug Application supported by results from the Phase 2b SunRISe-1 study RARITAN, N.J., JULY 17, 2025 – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug […]

FDA Grants Priority Review to NDA of TAR-200 in BCG-Unresponsive NMIBC

The FDA prioritizes TAR-200 for treating high-risk bladder cancer, showcasing promising phase 2b study results and innovative drug delivery.