JNJ - Johnson & Johnson Secures Complete FDA Approval For Bladder Cancer Drug Balversa After Almost Five Years Of Accelerated Approval | Benzinga
Friday afternoon, the FDA approved Johnson & Johnson’s (NYSE:JNJ) supplemental New Drug Application (sNDA) for Balversa (erdafitinib) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
Balversa is not recommended for patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
Balversa is the first oral FGFR kinase inhibitor to be approved and the ...