BALVERSA® (erdafitinib)

BALVERSA® (erdafitinib) is an oral, once-daily kinase inhibitor targeting fibroblast growth factor receptors (FGFR1, FGFR2, FGFR3, and FGFR4). It is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations (as determined by an FDA-approved companion diagnostic test), whose disease has progressed on or after at least one line of prior systemic therapy (including prior PD-1 or PD-L1 inhibitor therapy in certain settings).

• Dosage form:Film-coated tablets
• Available strengths:3 mg, 4 mg, and 5 mg
• Active ingredient:Erdafitinib (chemical formula: C₂₅H₃₀N₆O₂; molecular weight: 446.56)
• Appearance of API:Yellow powder, practically insoluble in aqueous media over a wide pH range
• Manufacturer/Marketing Authorization Holder:Janssen Biotech, Inc. (a Johnson & Johnson company) in the US; Janssen-Cilag International NV in Europe
• Approval status:FDA-approved (initially accelerated approval in 2019, with full updates including overall survival benefit data in 2024); positive CHMP opinion in Europe (2024) for specific FGFR3-altered cases