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FerringJapanannouncesPMDAAcceptanceofNDAFilingfornadofaragenefiradenovec
===2025-9-12 9:51:15===
se in 20 high-risk Japanese patients with carcinoma in situ (CIS), with or without concomitant high-grade Ta or T1 papillary lesions, was presented at the 112thAnnual Meeting of the Japanese Urological Association (JUA, April 17-19, 2025, Fukuoka). All treatment-related adverse events were limited to Grade 1 (84.2%) or Grade 2 (15.8%), with zero Grade 3, 4, or 5 adverse events reported - confirming the therapy's favourable safety and tolerability profile.1

These results are consistent with independent US real-world data presented by the Mayo Clinic, which demonstrated 79% complete response rate.2The results from the Mayo Clinic were achieved following a single quarterly dosing, representing clinical and convenience advantages over existing therapies, without requiring re-induction protocols.2Patients who achieved complete response continued quarterly maintenance dosing.

Joern Jakobsen, M.D., Ph.D., Vice President and Head of Global Research and Medical for Uro-O
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