Speedy approval for erdafitinib to treat bladder cancer

June 11, 2019 0 By FM

Erdafitinib (Balversa) has been granted accelerated approval by US FDA to treat adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2.

Patients should be selected for therapy with erdafitinib using an FDA-approved companion diagnostic device.

The efficacy of erdafitinib 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.

The overall response rate in these patients was 32.2%, with 2.3% having a complete response and almost 30% having a partial response. The response lasted for an average of approximately five-and-a-half months.

Responses to erdafitinib were seen in patients who had previously not responded to anti-PD-L1/PD-1 therapy.

Erdafitinib is the first approved drug in a class known as FGFR inhibitors that targets growth factor receptors involved in cell growth and division.