Posted by Michael Wonder on 26 Jun 2025
FDA grants RMAT designation for enGene’s detalimogene, enabling potential for expedited review in high risk, non-muscle invasive bladder cancer
25 June 2025 - enGene Holdings today announced that the US FDA has granted regenerative medicine advanced therapy designation to detalimogene voraplasmid (also known as detalimogene, and previously EG-70), the Company’s lead investigational therapy for the treatment of high risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ.
The designation was based on previously disclosed preliminary results from the on-going pivotal LEGEND study, which demonstrated compelling clinical activity and a generally favourable tolerability profile in patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
