Johnson & Johnson Announces FDA Priority Review For TAR-200 NDA

(RTTNews) - Johnson & Johnson (JNJ) announced that the FDA granted Priority Review to the New Drug Application filed for TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The regulatory submission is supported by data from the Phase 2b SunRISe-1 study.

TAR-200 is an investigational intravesical gemcitabine releasing system. In January 2025, Johnson & Johnson announced the initiation of a new drug application with the FDA for TAR-200 under the Real-Time Oncology Review program.

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