Therapeutic Response

FGFR3 p.S249C status confers therapeutic sensitivity to Erdafitinib in patients with Bladder Urothelial Carcinoma.

Statements

Source and description
Balversa (erdafitinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib's product label states for patients to be selected for therapy based on an FDA-approved companion diagnostic for erdafitinib. Furthermore, erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
Balversa (erdafitinib) [product monograph]. HC. 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.