USFDA approves Gene Therapy for Bladder Cancer

The therapy, Adstiladrin, is for patients with an aggressive form of the disease, whose current options include having their bladder removed.

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USFDA Approval
USFDA Approval

Last Updated on October 2, 2024 by The Health Master

Switzerland: The U.S. Food and Drug Administration (USFDA) approved Swiss drugmaker Ferring Pharmaceuticals’ first gene therapy for treating adult patients with a type of bladder cancer.

The therapy, Adstiladrin, is for patients with an aggressive form of the disease, whose current options include having their bladder removed.

The treatment, to be administered once every three months into the patient’s bladder, triggers the body to make a protein to fight off cancer.

The safety and effectiveness of Adstiladrin were evaluated in a multi-center clinical study that included 157 patients, the USFDA said.

Ferring said it was too early to comment on the pricing of Adstiladrin, but it is aiming to make the drug widely accessible to patients.

According to a 2021 report from the drug pricing research group Institute for Clinical and Economic Review, the drug provides a good value for patients when it is priced in the range of $158,600–$262,000.

Adstiladrin is expected to be commercially available in the United States in the second half of 2023, Ferring said.

Bladder cancer is one of the most common cancers in the United States, with non-muscle invasive bladder cancer (NMIBC) representing about 75 percent of all such cases.

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