FDA ap­proves Fer­ring's new gene ther­a­py for blad­der can­cer

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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