As Sio closes, former CEO from ‘vant exit finds himself at helm of Irv Weissman stealth biotech – Endpoints News
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Following a CRL in May 2021 due to CMC issues, the FDA this afternoon announced the approval of Ferring’s adenoviral vector-based gene therapy Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
The approval is based on a single-arm trial of 157 patients with high-grade non-muscle invasive bladder cancer, where investigators zeroed in on a subgroup — 103 patients with carcinoma in situ, i.e. bladder cancer that is confined to the superficial layer, with or without concomitant high-grade Ta or T1 papillary disease — for the primary endpoint.
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