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FerringJapanannouncesPMDAAcceptanceofNDAFilingfornadofaragenefiradenovec
===2025-9-12 9:51:15===
complete response or were free from high-grade recurrence at 3 months. 62% maintained this response at 6 months. 94% avoided bladder removal surgery (cystectomy). 100% were still alive at 6 months.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC affects the superficial bladder layer without deeper invasion or metastatic spread. Bladder cancer represents a major clinical challenge as the 13thmost commonly diagnosed cancer in Japan and ninth globally,4with 75% presenting as NMIBC in 2022.4While intravesical BCG remains first-line standard care for high-risk NMIBC, over 50% of patients experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease requiring radical intervention.5

Current treatment options remain limited for BCG-unresponsive patients, with JUA guidelines recommending only radical cystectomy or clinical trial participation.6Nadofaragene firadenovec offers the first choice non-chemotherapy ge
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