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# FDA RMAT Designation for Detalimogene
- URL: https://www.fdaweb.com/fda-rmat-designation-for-detalimogene/
- Published: 2025-06-26T12:00:00.000Z
- Updated: 2026-09-14T15:15:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159427

FDA has granted regenerative medicine advanced therapy designation for enGene Holdings’ detalimogene voraplasmid, the company’s lead investigational therapy to treat high-risk, Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. A company [statement](https://www.businesswire.com/news/home/20250625944717/en/FDA-Grants-RMAT-Designation-for-enGenes-Detalimogene-Enabling-Potential-for-Expedited-Review-in-High-Risk-Non-Muscle-Invasive-Bladder-Cancer?ref=fdaweb.com) describes detalimogene as a novel non-viral gene-based immunotherapy for patients with high-risk non-muscle invasive bladder cancer with carcinoma, including Bacillus Calmette-Guérin-unresponsive disease. The company says it is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response. Detalimogene has also received FDA fast-track designation.