Shots:
- FDA received NDA of TAR-200 (J&J) for the treatment of Bacillus Calmette-Guérin (BCG) -unresponsive HR-NMIBC with CIS &/or papillary tumors the application will be reviewed under RTOR pathway, following receipt of BTD in Dec 2023
- The NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in patients ineligible or opting out of radical cystectomy that showed 83.5% CR (1EP) & 82% sustained response at 9mos. median follow-up without the need for reinduction plus favorable safety. Data was presented at ESMO’24
- TAR-200 is an intravesical drug-releasing system that is responsible for the sustained release of gemcitabine into the bladder for the treatment of NMIBC
Ref: Johnson & Johnson | Image: Johnson & Johnson
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