4 December 2023 - Breakthrough therapy designation for novel targeted releasing system based on results from on-going Phase 2b SunRISe-1 study.
Johnson & Johnson announced today that the US FDA has granted TAR-200 breakthrough therapy designation for the potential future treatment of patients with Bacillus Calmette-Guérin unresponsive high risk non-muscle invasive bladder cancer, who are ineligible for or elected not to undergo radical cystectomy.