EC Approves J&J's Balversa for Bladder Cancer

Johnson & Johnson’s (J&J) Balversa (erdafitinib) has received approval from the European Commission (EC) for the treatment of a specific group of bladder cancer patients. This pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor has been sanctioned for use as a once-daily oral medication. It is designated for adults with unresectable or metastatic urothelial carcinoma (UC) who possess certain FGFR3 genetic alterations.

Eligible patients for this treatment must have undergone at least one previous therapy involving a PD-1 or PD-L1 inhibitor for their unresectable or metastatic condition. Europe holds the highest incidence of bladder cancer worldwide, with nearly 250,000 cases identified in 2022. Urothelial carcinoma is the predominant form of bladder cancer, and about 20% of patients with metastatic UC exhibit FGFR alterations.

The EC’s approval of Balversa marks it as the first pan-FGFR kinase inhibitor sanctioned in the European Economic Area for adults with unresectable or metastatic UC with susceptible FGFR3 alterations. This decision was bolstered by positive results from cohort one of the late-stage THOR trial. Balversa showed a 36% reduction in the risk of death compared to chemotherapy in patients with metastatic or unresectable UC and specific FGFR gene alterations who had previously been treated with an anti-PD-L1 agent.

Henar Hevia, senior director and EMEA therapeutic area lead for oncology at J&J Innovative Medicine, emphasized the critical role of targeted therapies like Balversa in addressing the unique genetic and disease characteristics of UC patients. Hevia also highlighted the importance of FGFR testing for all patients with metastatic UC and the need for a multi-disciplinary team approach to optimize patient outcomes.

Earlier this year, Balversa received full approval from the US Food and Drug Administration (FDA) for adults with locally advanced or metastatic UC with susceptible FGFR3 genetic alterations. This approval came after the drug had been granted accelerated approval by the US regulator in 2019.

Currently, Balversa is being evaluated in an early-stage trial for patients with non-muscle invasive or muscle invasive bladder cancer that have specific FGFR alterations. Additionally, a phase 3 trial is underway for patients with intermediate-risk non-muscle invasive bladder cancer.