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FDA Approves First Gene Therapy for Specific Form of Bladder Cancer

FDA Approves First Gene Therapy for Specific Form of Bladder Cancer

The FDA has approved Ferring’s gene therapy Adstiladrin to treat adults with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer — the first gene therapy approved for this patient population.

Bacillus Calmette-Guérin immunotherapy is still the standard of care as first-line treatment in patients with high-grade non-muscle invasive bladder cancer, but many patients become unresponsive to the treatment.

Adstiladrin (nadofaragene firadenovec-vncg) is administered through a catheter into the bladder once every three months. The FDA approval was supported by results from a clinical trial in which 51 percent of participants achieved a complete response and 46 percent of responding patients sustained the response for at least one year.

Ferring’s application received Breakthrough Therapy and Fast Track designations as well as a Priority Review.

Ferring Pharmaceuticals

Ferring Pharmaceuticals is a Swiss multinational biopharmaceutical company specialising in areas such as reproductive health, maternal health, gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years.

Headquartered in Saint-Prex, Switzerland, Ferring has its own manufacturing facilities in several European countries, in South America, China, India, and the United States. Founded in 1950, privately-owned Ferring employs more than 5,400 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

December 20, 2022


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