Posted by Michael Wonder on 18 Dec 2022
FDA approves first gene therapy for the treatment of high risk, non-muscle invasive bladder cancer
16 December 2022 - Today, the US FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating 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 with carcinoma in situ with or without papillary tumours.
The safety and effectiveness of Adstiladrin was evaluated in a multi-centre clinical study that included 157 patients with high-risk BCG unresponsive non-muscle invasive bladder cancer, 98 of whom had BCG unresponsive carcinoma in situ with or without papillary tumours and could be evaluated for response.
