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.
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.
This statement is based on a regulatory approval from the Food and Drug Administration:
BALVERSA is a kinase inhibitor indicated 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. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.