FX.co ★ Janssen-Cilag's Balversa Gets EC Approval For Metastatic Urothelial Carcinoma

Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (JNJ), announced on Friday that the European Commission has approved Balversa (Erdafitinib) for once-daily oral administration. This treatment is designated for adult patients with unresectable or metastatic urothelial carcinoma who possess fibroblast growth factor receptor 3 (FGFR3) mutations.

Henar Hevia, Senior Director of Oncology at Johnson & Johnson Innovative Medicine, commented, "The approval of erdafitinib as a precision therapy underscores the critical value of FGFR testing for all metastatic urothelial cancer patients. It also emphasizes the necessity of a multidisciplinary team approach to optimize patient outcomes."

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