The US Food and Drug Administration (FDA) has granted accelerated approval to Janssen's Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer.
The decision allows the drug use to treat 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.
The governing body announced that patients should be selected for therapy with Balversa using an FDA-approved companion diagnostic device.
Clearance was based on 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.
Richard Pazdur,director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said the approval "represents the first personalised treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer".
“FGFRs regulate important biological processes including cell growth and division during development and tissue repair. This drug works by targeting genetic alterations in FGFRs.”
The most common type of bladder cancer is transitional cell carcinoma, also called urothelial carcinoma. Bladder cancer is the sixth most common cancer in the United States and fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer.