FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer (Cell and Gene Therapy Catapult - Regulatory Round-up - December 2022)
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17 mai 2023
- handle: 10670/1.qjjg2n
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Therapy, Gene Carcinoma Cancers Malignancy (Cancer) Malignant tumorsCiter ce document
adelage, « FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer (Cell and Gene Therapy Catapult - Regulatory Round-up - December 2022) », ELSIBI, ID : 10670/1.qjjg2n
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On the 16th of December 2022, the U.S. Food and Drug Administration granted approval of Adstiladrin to Ferring Pharmaceuticals A/S. Adstiladrin (nadofaragene firadenovec-vncg) is a non-replicating (cannot multiply in human cells) 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. See all of Catapult...