FDA Grants RMAT Designation to Detalimogene in BCG-Unresponsive NMIBC

Ongoing Investigations: Expanding the Role of Cretostimogene in NMIBC Care

Panelists discuss the expanding clinical development of cretostimogene across multiple NMIBC populations and treatment strategies, highlighting ongoing trials exploring its use as monotherapy and in combination with agents like gemcitabine or pembrolizumab, with the goal of optimizing efficacy, safety, and bladder preservation across diverse risk groups.

FDA Grants RMAT Designation to Detalimogene in BCG-Unresponsive NMIBC

Detalimogene voraplasmid demonstrated a 71% any-time CR rate in this non-muscle invasive bladder cancer population in the phase 1/2 LEGEND trial.

FDA Grants RMAT Designation for Detalimogene in NMIBC

Detalimogene voraplasmid gains FDA RMAT designation, showcasing a 71% response rate in treating high-risk, BCG-unresponsive NMIBC with promising safety.