Therapeutic Response

FGFR3::TACC3 status confers therapeutic sensitivity to Erdafitinib in patients with Bladder Urothelial Carcinoma.

Statements

Source and description
Balversa (erdafitinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized erdafitinib for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting. This indication is based on BLC3001 Study Cohort 1, a Phase 3, randomised, open-label, multicentre study, where eligible patients were required to have at least one of the following FGFR fusions: FGFR2::BICC1, FGFR2::CASP7, FGFR3::TACC3, FGFR3::BAIAP2L1; or 1 of the following FGFR3 gene mutations: R248C, S249C, G370C, Y373C.
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.