Ferring’s Adstiladrin (nadofaragene firadenovec-vncg) Receives the US FDA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Shots:
- The US FDA has approved Adstiladrin for the treatment of adult patients with high-risk, BCG-unresponsive NMIBC with carcinoma in situ with/out papillary tumors. The therapy is expected to be available in the US in H2’23
- The approval was based on the P-III study results evaluating the efficacy and safety of Adstiladrin (q3mos.) in 157 patients. The trial met its 1EPs which showed that 51% of CIS ± Ta/T1 patients achieved a CR @3mos. & were remain free of high-grade recurrence (46%) @12mos.
- Adstiladrin is a novel adenovirus vector-based gene therapy & has been studied in a clinical trial program in the same indication who had prior been treated with adequate BCG
Ref: Ferring | Image: Ferring
Related News:- Ferring Signs an Exclusive License Agreement with Invo for its INVOcell Intravaginal Culture (IVC) System in the US
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