Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FGFR3 p.G370C status confers therapeutic sensitivity to Erdafitinib in patients with Bladder Urothelial Carcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved erdafitinib as a treatment option 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.
This statement is based on a regulatory approval from the Health Service Executive:
As monotherapy 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.