Janssen-Cilag International, a Johnson & Johnson (J&J) company, has received the European Commission (EC) approval for Balversa (erdafitinib) to treat a type of bladder cancer.
Balversa is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor.
It is indicated for adults with unresectable or metastatic urothelial carcinoma (mUC), with susceptible FGFR3 genetic alterations and previously treated with a PD-1 or PD-L1 inhibitor.
Balversa is the first pan-FGFR kinase inhibitor approved in the European Economic Area, in the current indication, said the US drugmaker.
Johnson & Johnson Innovative Medicine EMEA oncology therapeutic area lead senior director Henar Hevia said: “This important milestone emphasises the vital role of targeted therapies in addressing the unique genetic and disease characteristics of patients living with urothelial cancer, and reinforces our dedication to advancing cutting-edge, precision treatments in oncology.
“The approval of erdafitinib as a precision therapy further highlights the importance of FGFR testing for all patients with metastatic urothelial cancer, and the need for a multi-disciplinary team approach to optimise outcomes for each patient.”
The EC approval is based on the results from Cohort 1 of the Phase 3 THOR study, which evaluated the efficacy and safety of Balversa versus chemotherapy.
The Phase 3 THOR study was halted in June last year, following the interim efficacy analysis, based on the recommendation of the independent data safety monitoring committee.
In the study, all patients randomised to receive chemotherapy, comprising docetaxel or vinflunine, were offered to receive Balversa as crossover therapy.
The study results showed a median overall survival (OS) of over one year for patients receiving Balversa, a significant improvement compared to those in the chemotherapy arm.
It also showed that the drug resulted in an improved median progression-free survival (PFS) of 2.7 months compared to 5.6 months with chemotherapy, said the US drugmaker.
Johnson & Johnson Innovative Medicine solid tumours clinical development vice president Kiran Patel said: “The EC approval of erdafitinib reflects our unwavering commitment to transforming outcomes for people living with unresectable or metastatic urothelial carcinoma.
“We look forward to continuing our research and development efforts to bring new hope and improved outcomes to more patients in the future.”
