CG Oncology’s Cretostimogene Grenadenorepvec Receives FTD and BTD from the US FDA for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Shots:
- The FTD and BTD were granted based on the P-III (BOND-003) trial results for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ with/without Ta or T1 (papillary) tumors
- The interim trial results, as of Oct 05, 2023 cutoff in 66 evaluable patients, demonstrated CR rate of 75.7% at any time and the drug was well tolerated without grade 3 or higher TRAEs. The results were highlighted at SUO’23
- Cretostimogene grenadenorepvec, intravesically administered immunotx., is also being assessed in the P-II (CORE-001) study combined with pembrolizumab for same indication as well as in an investigator-sponsored study in combination with nivolumab for muscle invasive bladder cancer
Ref: CG Oncology | Image: CG Oncology
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
