Johnson & Johnson announced that FDA approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
👉 BALVERSA® is the first and only targeted therapy for patients with locally advanced or metastatic urothelial carcinoma and susceptible fibroblast growth factor receptor alterations.
👉 Phase 3 THOR study showed a 36 percent reduction in the risk of death with BALVERSA® versus chemotherapy in patients.
👉 Data were featured at the European Society for Medical Oncology (ESMO) 2023 congress and in the New England Journal of Medicine.
“Based on results from randomized Phase 3 data, BALVERSA continues to demonstrate the promise of targeted therapy in the treatment of patients with advanced bladder cancer,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. “This important milestone reinforces our commitment to advance innovative, precision therapies in oncology and confirm the role of targeted therapy in the treatment of bladder cancer.”
👉 U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations – Johnson & Johnson (jnj.com)
