This approval marks the first pan-FGFR kinase inhibitor approved in the European Economic Area for this indication, providing a significant advancement for patients who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor.
The approval is based on data from the phase 3 Thor study, which demonstrated a 36% reduction in the risk of death with erdafitinib compared to chemotherapy. “Bladder cancer remains one of Europe's most common cancers, and there is a high unmet need for innovative treatments for those with unresectable or metastatic urothelial carcinoma," said Dr Yohann Loriot of the Institut Gustave Roussy and University of Paris-Saclay. “Erdafitinib offers a novel, targeted therapy option that significantly improves survival outcomes for patients with FGFR3 alterations.”
Europe reports the highest rate of bladder cancer globally, with nearly a quarter of a million people diagnosed in 2022, representing a 10% increase from 2020. Urothelial carcinoma (UC), the most prevalent form of bladder cancer, has particularly poor outcomes for patients with metastasis, with only 8% surviving for five years post-diagnosis.
In the THOR study, erdafitinib showed a median overall survival (OS) of 12.1 months, a significant improvement compared to 7.8 months with chemotherapy. The study also showed a progression-free survival (PFS) of 5.6 months for erdafitinib versus 2.7 months with chemotherapy, along with a confirmed overall response rate (ORR) of 35.3% versus 8.5%.
“This important milestone emphasizes the role of targeted therapies in addressing the unique genetic characteristics of patients with urothelial cancer,” said Dr. Henar Hevia, senior director, EMEA therapeutic area lead, oncology, Johnson & Johnson Innovative Medicine. “The approval of erdafitinib highlights the necessity of FGFR testing for all patients with metastatic urothelial cancer, ensuring optimized treatment strategies.”
The EC’s approval reflects Johnson & Johnson’s commitment to transforming outcomes for patients with metastatic urothelial carcinoma. Kiran Patel, vice president, clinical development, solid tumours, Johnson & Johnson Innovative Medicine, said: “We are dedicated to advancing research and developing precision treatments that offer new hope and improved outcomes for patients.”
The approval of Balversa adds a crucial option to the treatment landscape for mUC, especially for those with FGFR3 alterations, and underscores the growing importance of personalized medicine in oncology.
