EC Approves Balversa for Metastatic Urothelial Carcinoma

Erdafitinib, a new pan-FGFR kinase inhibitor, has received approval in the European Economic Area for treating urothelial carcinoma, offering a major breakthrough for patients who have previously undergone at least one line of therapy involving a PD-1 or PD-L1 inhibitor. This approval is bolstered by data from the phase 3 Thor study, which indicated that erdafitinib resulted in a 36% reduction in the risk of death compared to traditional chemotherapy.

Bladder cancer remains a pressing health issue in Europe, being one of the continent's most common cancers. Dr. Yohann Loriot of the Institut Gustave Roussy and University of Paris-Saclay noted the high unmet need for innovative treatments for patients with unresectable or metastatic urothelial carcinoma. Erdafitinib offers a new targeted therapy that significantly enhances survival outcomes for patients with FGFR3 alterations, providing much-needed hope.

Statistics reveal that Europe has the highest incidence of bladder cancer globally, with nearly 250,000 people diagnosed in 2022—a 10% increase from 2020. Urothelial carcinoma (UC), the most prevalent type of bladder cancer, poses dire prognoses for patients with metastasis, as only 8% survive for five years post-diagnosis.

The THOR study underscored the efficacy of erdafitinib, showing a median overall survival (OS) of 12.1 months, a marked improvement over the 7.8 months observed with chemotherapy. Additionally, the study highlighted a progression-free survival (PFS) of 5.6 months for patients treated with erdafitinib, compared to 2.7 months with chemotherapy. The overall response rate (ORR) was also significantly higher at 35.3% for erdafitinib recipients, versus 8.5% for those undergoing chemotherapy.

Dr. Henar Hevia, senior director and EMEA therapeutic area lead in oncology at Johnson & Johnson Innovative Medicine, emphasized the importance of targeted therapies in addressing the unique genetic features of urothelial cancer patients. This approval of erdafitinib accentuates the necessity of FGFR testing for all patients with metastatic urothelial cancer to ensure optimal treatment strategies.

Johnson & Johnson’s commitment to improving outcomes for patients with metastatic urothelial carcinoma is reflected in the European Commission's (EC) approval of erdafitinib. Kiran Patel, vice president of clinical development for solid tumors at Johnson & Johnson Innovative Medicine, stated that the company is dedicated to advancing research and developing precision treatments to offer new hope and better outcomes for patients.

The approval of Balversa (erdafitinib) introduces a crucial new option to the treatment landscape for metastatic urothelial carcinoma (mUC), particularly benefiting those with FGFR3 alterations. This development underscores the growing significance of personalized medicine in oncology, as targeted therapies continue to transform treatment approaches and improve patient outcomes.