New 36-month follow-up data from Phase III study of gene therapy Adstiladrin (nadofaragene firadenovec-vncg) presented at conference

Analysis (n=157) noted a sustained durability of response with data showing that at 36-month mark, a quarter of patients remained free of high-grade recurrence. A 90% 3-year overall survival rate was observed and 53.8% of patients were cystectomy-free at 36 months.

SPS commentary:

Adstiladrin is the first FDA-approved intravesical gene therapy to be authorised for adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumours.

European Pharmaceutical Review