The European Commission (EC) has approved company Janssen-Cilag International’s BALVERSA (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma (mUC). This once-daily oral monotherapy is intended for patients with mUC harbouring susceptible FGFR3 genetic alterations, who have previously undergone a minimum of one line of therapy including a PD-1 or PD-L1 inhibitor. The gold standard of business intelligence.
Erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, received approval based on data from the Cohort 1 of the Phase III THOR clinical trial. This trial assessed the efficacy and safety of erdafitinib versus chemotherapy. In June last year, the THOR study was halted early due to its interim efficacy analysis, as recommended by the independent data safety monitoring committee.
Patients initially randomised to chemotherapy were subsequently offered erdafitinib as crossover therapy. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The study demonstrated that patients treated with erdafitinib had a median overall survival (OS) of over one year at the data cut-off, a .