Shots:
- The US FDA has granted priority review to NDA of TAR-200 for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors
- NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in pts ineligible or opting out of radical cystectomy that showed an 82.4% CR rate & 52.9% remained cancer-free for at least 1yr. post-response. Data was presented at AUA 2025
- TAR-200 is an intravesical drug-releasing system that is responsible for the sustained release of gemcitabine into the bladder & is also being evaluated in SunRISe-3 & SunRISe-5 for NMIBC as well as SunRISe-4 for MIBC
Ref: PRNewswire | Image: Johnson & Johnson | Press Release
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