BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has...susceptible FGFR3 or FGFR2 genetic alterations and...progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Patients were aged ≥18 years with histologically confirmed BCG-unresponsive HR-NMIBC presenting as CIS with FGFR3/2 alterations with or without a papillary tumor and either refused or were ineligible for cystectomy….Patients received oral erdafitinib at 6 mg once daily without uptitration in 28-day cycles (dose selected to improve tolerability)....CR rate in disease-evaluable patients was 93.8% and 72.7% at 8 and 32 weeks, respectively (Table). Median duration of response was not reached, with 12 responses ongoing (Figure).

We report a longer follow-up of an exploratory marker lesion cohort of patients with IR NMIBC (Cohort 3) from the multicohort phase 2 THOR-2 study (NCT04172675) of erdafitinib in patients with NMIBC with FGFR3/2 alterations….In this marker lesion study of an FGFR-targeted therapy, erdafitinib demonstrated efficacy in all treated patients with IR NMIBC with FGFR alterations. Safety data were consistent with the known safety profile of erdafitinib.