Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FGFR3 p.R248C status confers therapeutic sensitivity to Erdafitinib in patients with Bladder Urothelial Carcinoma.
Health Canada approved erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC) harboring susceptible FGFR3 genetic alterations, who have experienced disease progression during or after at least one line of prior therapy, including within 12 months of neoadjuvant or adjuvant therapy.
This statement is based on a regulatory approval from the Health Canada:
BALVERSA (erdafitinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, who have disease progression during or following at least one line of prior therapy including within 12 months of neoadjuvant or adjuvant therapy.