Balversa (erdafitinib) has been approved by the Ministry of Health of the Russian Federation the drug for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Balversa is a once-daily oral FGFR kinase inhibitor, received accelerated approval based on results from a Phase 2 clinical trial, a multicenter, open-label, single-arm study, of 87 patients with disease that had progressed on or after at least one prior chemotherapy and that had at least one of the following genetic alterations.
The drug the first FGFR kinase inhibitor approved by the FDA.