J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment

The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who have received at least one prior line of systemic therapy. This decision follows positive Phase III clinical trial results, which demonstrated that the first-in-class drug lowered the risk of death by 36% and extended overall survival (OS) by over four months compared to standard chemotherapy, meeting the study’s primary endpoint.- Flcube.com