Johnson & Johnson’s (J&J) Balversa (erdafitinib) has been granted approval by the European Commission (EC) to treat a subset of bladder cancer patients.
The pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor has been authorised as a once-daily oral monotherapy for adults with unresectable or metastatic urothelial carcinoma (UC) who are harbouring susceptible FGFR3 genetic alterations.
Patients eligible for the drug will also have received at least one prior line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
Europe has the highest rate of bladder cancer compared to all continents globally, with almost 250,000 cases diagnosed in 2022.
UC is the most common form of the disease and up to 20% of patients with metastatic UC have FGFR alterations.
The EC’s decision makes Balversa the first pan-FGFR kinase inhibitor to be approved in the European Economic Area for adults with unresectable or metastatic UC and susceptible FGFR3 alterations and was supported by positive results from cohort one of the late-stage THOR trial.
Balversa demonstrated a 36% reduction in the risk of death versus chemotherapy in patients with metastatic or unresectable UC and selected FGFR gene alterations who had received prior treatment with an anti-PD-L1 agent.
Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, said the approval “emphasises the vital role of targeted therapies in addressing the unique genetic and disease characteristics of patients living with UC”.
Hevia added that the authorisation also “further highlights the importance of FGFR testing for all patients with metastatic UC, and the need for a multi-disciplinary team approach to optimise outcomes for each patient”.
Balversa received full approval from the US Food and Drug Administration in January this year for adults with locally advanced or metastatic UC with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, after being granted accelerated approval by the US regulator in 2019.
The drug is also currently being evaluated in an early-stage trial of patients with non-muscle invasive or muscle invasive bladder cancer with selected FGFR alterations, and in a phase 3 trial in those with intermediate risk non-muscle invasive bladder cancer.