Shots:
- Japan’s PMDA has accepted the NDA of nadofaragene firadenovec (intravesically; Q3W) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS ± papillary tumors (Ta/T1)
- NDA was backed by P-III study evaluating nadofaragene in 157 pts, where 5yr. follow-up data showed OS rate of 80% & a 49% cystectomy-free survival in adults with CIS ± papillary tumors or high-grade Ta/T1 without CIS
- RWE showed that after a mFU of 8.2mos., among 29/45 BCG-unresponsive NMIBC pts treated with nadofaragene at Mayo Clinic sites (Nov 2023–Oct 2024), 72% had CR/no high-grade recurrence at 3mos., 62% at 6mos., 94% avoided cystectomy, & 100% were alive at 6mos.
Ref: Ferring | Image: Ferring | Press Release
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