Janssen-Cilag's Balversa Gets EC Approval For Metastatic Urothelial Carcinoma

(RTTNews) - Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (JNJ), announced on Friday that the European Commission has approved Balversa or Erdafitinib, as a once-daily oral treatment for adult patients with unresectable or metastatic urothelial carcinoma, with fibroblast growth factor receptor 3.

Henar Hevia, senior director of Oncology at Johnson & Johnson Innovative Medicine, said, "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."

This approval was granted based on findings from Cohort 1 of the Phase 3 THOR study, which demonstrated that erdafitinib reduced the risk of death by 36% compared to chemotherapy.