FDA Grants RMAT Designation to Detalimogene for High-Risk Bladder Cancer
The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid for treating high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
enGene's Detalimogene Shows Promise in BCG-Unresponsive Bladder Cancer
enGene's detalimogene voraplasmid demonstrates a 71% complete response rate in patients with BCG-unresponsive NMIBC with CIS in the LEGEND study.