FDA approves 1st gene therapy for bladder cancer

The FDA approved Adstiladrin, the first gene therapy to treat high-risk, non-muscle-invasive bladder cancer, Dec. 16. 

Adult patients with bladder cancer who have a high risk of not responding to Bacillus Calmette-Guérin — a tuberculosis vaccine and the most common intravesical immunotherapy for early-stage bladder cancer — with carcinoma in situ are now eligible for the biologic. 

Annually, about 20 percent of the 57,000 men and 40 percent of the 18,000 women diagnosed with bladder cancer die, according to the FDA. In a clinical study, the gene therapy was 51 percent effective in a total disappearance of all cancer signs. 

In 2021, the Institute for Clinical and Economic Review estimated the drug should cost between $158,600 and $262,000 based on its therapeutic value, but Ferring Pharmaceuticals has not yet published a market price.

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