Posted by Michael Wonder on 13 Apr 2019
FDA approves first targeted therapy for metastatic bladder cancer
12 April 2019 - The U.S. FDA today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.
Patients should be selected for therapy with Balversa using an FDA-approved companion diagnostic device.
The efficacy of Balversa was studied in a clinical trial that included 87 patients with locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations, that had progressed following treatment with chemotherapy.
