Erdafitinib (pan-FGFR inhibitor) delivers 55% CR chemoablation in FGFR3-mutant recurrent NMIBC

Oral erdafitinib, a pan-FGFR1–4 tyrosine kinase inhibitor approved in metastatic urothelial carcinoma, was tested as short “chemoablation” in a Phase II window-of-opportunity study before TURBT in recurrent FGFR3-altered NMIBC (NCT04917809). Across 20 patients with FGFR3-mutant NMIBC (70% prior low-grade Ta; all had ≥1 prior intravesical therapy and 55% had multiple prior intravesical courses), 28 days of erdafitinib 6mg daily produced a RECIT-Bladder ORR of 75% (15/20) including 55% CR (11/20), with no grade ≥3 toxicities reported—an attractive tolerability profile versus intravesical approaches (e.g., BCG/mitomycin/gemcitabine) that reduce recurrence risk but are not typically “chemoablative” in a single pre-TURBT window and can drive local/systemic AEs and treatment discontinuations in real-world practice. FGFR3 alterations are enriched in NMIBC (often cited up to ~80% in some NMIBC series, though estimates vary by cohort/assay), making this a biomarker-defined strategy with potentially meaningful reach if durability holds.