The FDA has granted accelerated approval and a breakthrough designation to erdafitinib (Balversa, Janssen Pharmaceutical) for adults with advanced or metastatic bladder cancer with fibroblast growth factor (FGFR) genetic alterations FGFR3 or FGFR2, that has progressed during or after prior chemotherapy.
Bladder cancer is the sixth most common cancer in the U.S. The most common type is urothelial carcinoma. (FGFR) alterations are present in approximately 20% of patients with recurrent and refractory bladder cancer.
Erdafitinib’s efficacy was studied in a clinical trial with 87 patients who had locally advanced or metastatic bladder cancer, with FGFR3/FGFR2 alterations, that had progressed after chemotherapy treatment. The overall response rate was 32.2%, and the response lasted for an average of approximately five-and-a-half months. Responses were also seen in patients who had previously not responded to anti PD-L1/PD-1 therapy.
Common side effects included increased phosphate level, mouth sores, tiredness, change in kidney function, diarrhea, dry mouth, nails separating from the bed or poor formation of the nail, change in liver function, low sodium levels, decreased appetite, change in sense of taste, anemia, dry skin, dry eyes, and hair loss.
Erdafitinib may cause inflamed eyes, inflamed cornea, and retinal disorders. Patients should have periodic eye exams and inform their health care professional immediately if they develop blurred vision, loss of vision, or other visual changes.
Women who are pregnant or breastfeeding should not take erdafitinib as it may harm the developing fetus or newborn.
Source: FDA, April 12, 2019