Dec 19, 2022

FDA Approves Gene Therapy for Tough-to-Treat Bladder Cancer

Posted by in categories: biotech/medical, health

MONDAY, Dec. 19, 2022 (HealthDay News) — Patients with a high-risk bladder cancer now have a new option to treat it.

The U.S. Food and Drug Administration on Friday approved a gene therapy called Adstiladrin, which is designed to work for patients who have what’s called high-risk non-muscle-invasive bladder cancer (NMIBC) that hasn’t responded to the standard treatment, Bacillus Calmette-Guérin (BCG), but hasn’t spread. BCG is a vaccine typically used for tuberculosis.

“This approval provides health care professionals with an innovative treatment option for patients with high-risk NMIBC that is unresponsive to BCG therapy,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release. “Today’s action addresses an area of critical need. The FDA remains committed to facilitating the development and approval of safe and effective cancer treatments.”

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