Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)
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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
