Posted by Michael Wonder on 29 Aug 2023
Janssen submits supplemental new drug application to the US FDA seeking full approval of Balversa (erdafitinib) for the treatment of patients with locally advanced or metastatic urothelial carcinoma and selected fibroblast growth factor receptor gene alterations
28 August 2023 - Submission based on confirmatory data from cohort 1 of the Phase 3 THOR study, which showed a 36 percent reduction in the risk of death in patients rreated with Balversa versus chemotherapy.
Janssen today announced the submission of a supplemental new drug application to the US FDA seeking full approval of Balversa (erdafitinib), a kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible fibroblast growth factor receptor3 genetic alterations, and progressed during or following at least one line of a programmed death receptor-1 or programmed death-ligand 1 inhibitor in the locally advanced or metastatic setting or within 12 months of neo-adjuvant or adjuvant therapy.
