J&J's Balversa earns EU nod as first precision therapy for FGFR3-altered bladder cancer

The European Commission has waved through Johnson & Johnson's Balversa (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma (mUC) carrying susceptible FGFR3 genetic alterations, making it the bloc's first pan-FGFR kinase inhibitor cleared for this patient population.

Friday's decision follows the full FDA approval of Balversa in January for a similar indication.

The EU filing, which received a positive opinion from the European Medicines Agency's drug advisory body in June, is based on results from Cohort 1 of the Phase III THOR study involving patients whose disease worsened on or after one or two prior treatments, at least one of which was an anti-PD-(L)1 agent. Results showed a 36% reduction in the risk of death with Balversa compared to chemotherapy.

Patients treated with Balversa achieved a median overall survival of 12.1 months, a significant 4.3 months longer than those receiving chemotherapy. The study also showed improvements in progression-free survival (5.6 months vs. 2.7 months) and overall response rate (35.3% vs. 8.5%) favouring Balversa.

"This important milestone emphasises the vital role of targeted therapies in addressing the unique genetic and disease characteristics of patients living with urothelial cancer," said Henar Hevia, EMEA therapeutic area lead for oncology at Johnson & Johnson Innovative Medicine. It also "highlights the importance of FGFR testing for all patients with metastatic urothelial cancer."

Europe has the highest rate of bladder cancer compared to all continents globally, with nearly a quarter of a million people diagnosed in 2022. J&J also estimates that up to 20% of patients with mUC have FGFR alterations.

Speaking to FirstWord last year, key opinion leader Jose Pablo Maroto Rey, head of the urologic oncology unit at Hospital de la Santa Creu i Sant Pau in Barcelona, suggested that the main competitor to Balserva would be the antibody-drug conjugate Padcev (enfortumab vedotin), marketed by Astellas and Pfizer.

"In the future, we need to know if those patients with FGFR mutations respond to other therapies. We don't know if these patients with the mutations are poor responders to enfortumab vedotin, meaning they should be treated first with FGFR inhibitors. The main competitors to these drugs will be other drugs developed in the third line," he said. For more on that interview, see – KOL Views Q&A: Leading oncologist says Balversa may have Padcev in its sites in 2L bladder cancer.