FDA OKs Bladder Cancer Gene Therapy
Less than one month after the FDA approved a gene therapy for hemophilia B, the agency today gave its OK to Ferring Pharmaceuticals for Adstiladrin (nadofaragene firadenovec-vncg). The product is a non-replicating adenoviral vector‑based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
“This approval provides healthcare professionals with an innovative treatment option for patients with high-risk non-muscle invasive bladder cancer that is unresponsive to BCG therapy,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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.”
Bladder cancer is one of the more common forms of cancer. These abnormal cells can invade and destroy normal body tissue. Over time, the abnormal cells can also metastasize through the body. Most newly diagnosed bladder cancers (75–80%) are classified as NMIBC—a type of cancer that has grown through the lining of the bladder but hasn’t yet invaded the muscle layer. This type of cancer is associated with high rates of recurrence (30–80%) and the risk of progression to invasive and metastatic cancer.
https://www.genengnews.com/topics/cancer/fda-oks-bladder-cancer-gene-therapy/
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