Johnson & Johnson (J&J) has announced that the European Medicines Agency’s human medicines committee has recommended approval of Balversa (erdafitinib) to treat a form of bladder cancer.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the once-daily oral monotherapy in adult patients with unresectable or metastatic urothelial carcinoma (UC) with 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.
UC accounts for approximately 90% of all bladder cancer cases, and up to 20% of patients with metastatic UC have FGFR genetic alterations.
Now considered the first targeted therapy to receive a positive CHMP recommendation in this patient population, the committee’s decision was based on positive data from cohort one of the phase 3 THOR study, which has been evaluating the efficacy and safety of Balversa versus chemotherapy in patients with metastatic or unresectable UC and selected FGFR alterations who had received prior treatment with an anti-PD-L1 agent.
The study met its primary endpoint of overall survival, with Balversa treatment demonstrating a 36% reduction in the risk of death compared to chemotherapy in patients.
Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, commented: “[The CHMP] recommendation… marks important progress towards transforming outcomes for patients diagnosed with bladder cancer with FGFR alterations.
“Pending approval, we look forward to providing eligible patients across the region with a new treatment option as soon as possible.”
This year, the FGFR tyrosine kinase inhibitor received approval from the US Food and Drug Administration to treat 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.
Balversa is also being investigated as a once-daily oral tablet to treat high-risk non-muscle-invasive bladder cancer, locally advanced or metastatic UC with FGFR3 or FGFR2 gene alterations, advanced solid tumours driven by FGFR1 to 4 alterations, non-muscle-invasive or muscle-invasive bladder cancer with selected FGFR alterations and bladder cancer.