Balversa (erdafitinib) is one of the first fibroblast growth factor receptor (FGFR) kinase inhibitors to be approved for the treatment of locally advanced or metastatic bladder cancer.
This indication for Balversa applies to patients who harbor FGFR3 or FGFR2 mutations according to the FDA-approved companion diagnostic device, therascreen FGFR RGQ RT-PCR Kit (QIAGEN Manchester).
The approval of Balversa is supported by a data from a clinical trial of 87 patients with locally advanced or metastatic bladder cancer and FGFR3 or FGFR2 genetic alterations. All patients had progressed after treatment with chemotherapy. Results showed an overall response rate of 32.2%, which included a 2.3% complete response rate and a nearly 30% partial response rate. Mean duration of response was about 5.5 months.
Approximately a quarter of patients had been treated with anti-PD-L1/PD-1 therapy; researchers observed responses to erdafitinib even among patients who had not responded to this prior therapy.
Common side effects include mouth sores, feeling tired, changes in kidney or liver function, diarrhea, dry mouth, changes in fingernails or toenails, changes in mineral levels in the blood (such as phosphate and sodium), loss of appetite, changes in how things taste, low red blood cell counts (anemia), dry skin, dry eyes, and hair loss. Other side effects can include hand-foot syndrome (redness, swelling, peeling or tenderness on the hands or feet), constipation, belly pain, nausea, and muscle pain.
The FDA advises people taking Balversa to have regular eye exams because Balversa can cause serious eye problems, too. Patients should also have their blood phosphate level checked regularly.
The FDA granted the approval of Balversa to Janssen Pharmaceutical.
