erdafitinib (Balversa)

following a full submission assessed under the end of life and orphan equivalent medicine process:

erdafitinib (Balversa®) is accepted for use within NHSScotland.

Indication under review: 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.

In a phase III study of patients with metastatic UC and fibroblast growth factor receptor (FGFR) alterations who had progression after one or two previous treatments that included a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, erdafitinib significantly improved overall survival compared with investigators choice of single agent chemotherapy.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.