Johnson & Johnson granted FDA Priority Review for TAR-200 NDA

Johnson & Johnson announced that the FDA granted Priority Review to the New Drug Application, or NDA, filed for TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guerin-unresponsive high-risk non-muscle invasive bladder cancer, or HR-NMIBC, with carcinoma in situ, or CIS, with or without papillary tumors. The regulatory submission is supported by data from the Phase 2b SunRISe-1 study, which demonstrated an 82.4% complete response rate with 52.9% of patients remaining cancer-free at least one year or more after achievement of a CR. The majority of adverse reactions were mild and moderate.