Janssen's BALVERSA Approved by EC for Metastatic Urothelial Carcinoma

The European Commission (EC) has granted approval for Johnson & Johnson’s Janssen-Cilag International to market BALVERSA (erdafitinib), a treatment for adults with unresectable or metastatic urothelial carcinoma (mUC). This oral medication, taken once daily, is specifically designed for mUC patients with susceptible FGFR3 genetic alterations, who have previously received at least one line of therapy, including a PD-1 or PD-L1 inhibitor.

Erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, earned its approval through data derived from Cohort 1 of the Phase III THOR clinical trial. This pivotal trial evaluated the efficacy and safety of erdafitinib in comparison to chemotherapy. Due to promising interim results, the THOR study was halted early in June last year following a recommendation from the independent data safety monitoring committee.

Patients initially randomized to the chemotherapy group were later given the option to switch to erdafitinib as part of crossover therapy. The results of the study highlighted significant benefits for those treated with erdafitinib. These patients experienced a median overall survival (OS) exceeding one year at the time of the data cut-off. Additionally, erdafitinib demonstrated a median progression-free survival (PFS) of 5.6 months, compared to just 2.7 months for the chemotherapy group. The overall response rate (ORR) was also notably higher for erdafitinib at 35.3%, in contrast to 8.5% for chemotherapy.

The safety profile of erdafitinib was promising as well. Serious treatment-related adverse events (TRAEs) were reported in 13.3% of patients on erdafitinib, which was lower than the 24.1% observed in the chemotherapy group. While Grade 3 or higher adverse events were similar between the two treatment groups, 8.1% of patients on erdafitinib discontinued treatment due to TRAEs, compared to 13.4% on chemotherapy.

Henar Hevia, Johnson & Johnson's lead for Innovative Medicine Oncology in the EMEA region, commented on the significance of this approval, emphasizing the crucial role of targeted therapies in addressing the unique genetic and disease characteristics of urothelial cancer patients. Hevia highlighted the company's commitment to advancing precision treatments in oncology and underscored the importance of FGFR testing for all patients with metastatic urothelial cancer. He also pointed out the need for a multi-disciplinary approach to optimize patient outcomes.

In a related development, Janssen-Cilag filed applications with the European Medicines Agency (EMA) in May to expand the marketing authorization for TREMFYA (guselkumab). The application seeks to include the treatment of adults with active ulcerative colitis and Crohn's disease, thereby broadening the therapeutic reach of TREMFYA.