FDA Approves BALVERSA® for mUC: Johnson & Johnson's Milestone

Johnson & Johnson received approval from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib), marking a significant development in cancer treatment. The approval targets adult patients with locally advanced or metastatic urothelial carcinoma (mUC) harboring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations. These are individuals whose disease has progressed after at least one prior systemic therapy. The FDA's decision converts the drug's accelerated approval in April 2019 to a full approval, backed by substantial clinical evidence, particularly from the Phase 3 THOR study.

Approximately 20 percent of mUC patients exhibit FGFR3 genetic alterations, constituting a significant target population. Following previous systemic treatments, including checkpoint inhibitors, these patients typically face grim prognoses with limited therapeutic avenues. The approval is rooted in the outcomes of Cohort 1 of the Phase 3 THOR study, affirming BALVERSA®'s efficacy in prolonging overall survival compared to chemotherapy in the second-line setting. Results showcased a notable 36 percent decrease in the risk of death with BALVERSA® versus chemotherapy among patients previously treated with PD-1 or PD-(L)1 inhibitors.

Dr. Kiran Patel, Vice President of Clinical Development for Solid Tumors at Johnson & Johnson Innovative Medicine, commented on the significance of this milestone. He emphasized BALVERSA®'s role in advancing precision therapies in oncology, particularly in addressing advanced bladder cancer.

The U.S. Prescribing Information for BALVERSA® outlines warnings and precautions, including ocular disorders, hyperphosphatemia, and embryo-fetal toxicity. Common adverse reactions (>20%) encompass various laboratory abnormalities and physical symptoms.

Johnson & Johnson is facilitating access to BALVERSA® and related patient services through a designated specialty pharmacy provider, US Bioservices. This streamlined approach underscores the company's ongoing dedication to delivering top-tier products, services, and support to healthcare professionals and patients alike.