FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer (Cell and Gene Therapy Catapult – Regulatory Round-up – December 2022)
On the 16th of December 2022, the U.S. Food and Drug Administration granted approval of Adstiladrin to Ferring Pharmaceuticals A/S. Adstiladrin (nadofaragene firadenovec-vncg) is a non-replicating (cannot multiply in human cells) adenoviral vector based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
See all of Catapult’s Regulatory Round-up for December 2022 here. Published on the 11th of January 2023.
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adelage (17 mai 2023). FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer (Cell and Gene Therapy Catapult – Regulatory Round-up – December 2022). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o6av





