FDA Grants Full Approval of Balversa in Bladder Cancer

The FDA has granted full approval for Johnson & Johnson’s Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma. Balversa is a kinase inhibitor for adult patients who have susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations and who progressed during or following treatment.

Balversa was granted accelerated approval in April 2019. Balversa 3 mg has a list price of $19,848.65 for 56 tablets, according to Drugs.com. J&J offers a copay program of $5 a prescription, with a maximum benefit of $25,000 annually.

Urothelial carcinoma is the most common form of bladder cancer, representing more than 90% of all bladder cancers. About 20% of patients diagnosed with metastatic urothelial carcinoma have an FGFR genetic alteration. The five-year survival rate for patients with Stage IV metastatic bladder cancer is 8%.

The full approval was based on results from Cohort 1 of the open-label phase 3 THOR study, which assessed overall survival (OS) compared with chemotherapy in the second-line setting. Results from the study showed a 36% reduction in the risk of death with Balversa versus chemotherapy in patients previously treated with a PD-1 or PD-(L)1 inhibitor, with those in the Balversa arm living a median of more than four months longer.

Results from Cohort 1 were presented at the 2023 American Society of Clinical Oncology Annual Meeting (Abstract #LBA4619) in June 2023 and were published in the New England Journal of Medicine in November 2023.

The most common (>20%) adverse reactions were increased phosphate, nail disorders, stomatitis, diarrhea, decreased hemoglobin, decreased sodium, increased aspartate aminotransferase, fatigue, dry mouth, dry skin, decreased phosphate, decreased appetite, constipation, increased calcium, dry eye, increased potassium, alopecia, and central serous retinopathy.