FDA approves gene therapy for high-risk non-muscle invasive bladder cancer treatment
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The FDA has approved a gene therapy treatment for adult patients with high-risk bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors, according to a press release.
The approval is supported by data from a multicenter clinical study that investigated the efficacy of nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals A/S), a non-replicating adenoviral vectorbased gene therapy, in treating high-risk bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer among 157 patients, in which patients received nadofaragene firadenovec-vncg once every 3 months for up to 1 year. In the study, 98 of the patients had BCG-unresponsive carcinoma in situ with or without papillary tumors and could be evaluated for response, according to the release.
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Among the patients treated with nadofaragene firadenovec-vncg gene therapy, 51% of enrolled patients treated with the gene therapy achieved complete response, in which the median duration of response was 9.7 months. Additionally, 46% of responding patients remained in complete response for at least 1 year.
Common adverse events among patients who received the gene therapy included bladder discharge, fatigue, bladder spasm, urinary urgency, hematuria, chills, fever and painful urination, according to the release.
“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," Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research, said in the 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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