European Commission approves Balversa (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma – Janssen Cilag (J&J)

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has approved Balversa (erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (mUC), harbouring 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.

“Bladder cancer is one of Europe’s most common cancers and the need for innovative treatment options for people living with unresectable or metastatic urothelial carcinoma remains high,” said Yohann Loriot, M.D., Ph.D., Institut Gustave Roussy and University of Paris-Saclay, France. “Erdafitinib is a novel, targeted therapy that has been shown to significantly improve overall and progression-free survival for patients with FGFR3 alterations, who, until now, have had limited options available.”

Europe has the highest rate of bladder cancer compared to all continents globally, with nearly a quarter of a million people diagnosed in 2022, representing a 10 percent increase from 2020. Urothelial carcinoma (UC) is the most common form of bladder cancer, and up to 20 percent of patients with mUC have FGFR alterations. Prognosis remains particularly poor for patients with mUC, with only eight percent of people diagnosed at a late metastatic stage surviving for five years.

Erdafitinib received EC approval based on results from Cohort 1 of the Phase III THOR study (NCT03390504), evaluating the efficacy and safety of erdafitinib (n=136) versus chemotherapy (n=130) in patients with advanced or mUC with select FGFR alterations who have progressed on or after one or two prior treatments, at least one of which includes an anti-PD-(L)1 agent.

In June 2023, based on the recommendation of the independent data safety monitoring committee, the THOR study was stopped following the interim efficacy analysis and all patients randomised to chemotherapy (docetaxel or vinflunine) were offered the opportunity to receive erdafitinib as crossover therapy.