Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with bladder cancer – locally advanced or metastatic urothelial carcinoma (mUC) with specific fibroblast growth factor receptor 3 (FGFR3) genetic alterations. This approval comes after patients have progressed on or after at least one prior systemic therapy. Notably, BALVERSA® is not advised for patients who are eligible but have not received prior PD-1 or PD-L1 inhibitor therapy.
Initially granted accelerated approval in April 2019, this FDA action transforms BALVERSA®’s status to full approval based on its demonstrated clinical benefits and overall survival advantage in the Phase 3 THOR study. BALVERSA® is notable as the first oral FGFR kinase inhibitor to be approved and the first and only targeted treatment for patients with bladder cancer and FGFR alterations, Approximately 20 percent of patients with bladder cancer have FGFR3 genetic alterations. These patients typically have a poor prognosis after systemic therapy, including a checkpoint inhibitor, leaving them with limited treatment options.
The FDA’s approval is based on results from Cohort 1 of the THOR study, which showed a significant reduction in the risk of death (36 percent) with BALVERSA® compared to chemotherapy in previously treated patients. The median overall survival in the BALVERSA® arm was over four months longer than those receiving chemotherapy. Kiran Patel, M.D., Vice President of Clinical Development for Solid Tumors at Johnson & Johnson Innovative Medicine, emphasized the promise of targeted therapy in treating advanced bladder cancer and reiterated the company’s commitment to advancing precision therapies in oncology.
Full FDA Approval of BALVERSA® Boosts Bladder Cancer Treatment, Showcasing Advances in Targeted Therapies
The U.S. Prescribing Information for BALVERSA® includes warnings and precautions for ocular disorders, hyperphosphatemia, and embryo-fetal toxicity. Common adverse reactions and laboratory abnormalities included increased phosphate, nail disorders, stomatitis, diarrhea, and other metabolic disturbances. The company is distributing BALVERSA® through US Bioservices, a single-source specialty pharmacy provider. This distribution model is part of Johnson & Johnson’s broader commitment to ensuring access to high-quality products and support for healthcare professionals and patients.
The full approval of BALVERSA® represents a significant development in the treatment landscape for patients with mUC, particularly those with FGFR3 genetic alterations. This approval underscores the potential of targeted therapies in oncology and reinforces Johnson & Johnson’s dedication to providing innovative treatment options and comprehensive support services to healthcare providers and patients. The successful outcomes of the THOR study indicate a substantial advancement in bladder cancer treatment, offering new hope and improved survival prospects for patients with advanced stages of this challenging disease.
Resource: Johnson & Johnson, January 20, 2024
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