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FDA Approves Gene Therapy Treatment for Certain Bladder Cancer

Dec. 16, 2022, 9:18 PM

The US Food and Drug Administration has approved Adstiladrin for treatment of adult patients with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors, according to a news release Friday.

Adstiladrin, which is a non-replicating adenoviral vector-based gene therapy, was evaluated in a multicenter clinical study in which 51% of enrolled patients using the therapy showed the disappearance of all signs of cancer as seen on cystoscopy, biopsied tissue, and urine with varying lengths of duration, according to the FDA.

The FDA said it granted Priority Review, Breakthrough Therapy, and Fast Track designations to ...