Balversa (erdafitinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Janssen Products, LP. Balversa (erdafitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf. Revised January 2024. Accessed October 30, 2024.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. 5

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) FGFR3 p.R248C Bladder Urothelial Carcinoma Erdafitinib
FDA (1) FGFR3 p.S249C Bladder Urothelial Carcinoma Erdafitinib
FDA (1) FGFR3 p.G370C Bladder Urothelial Carcinoma Erdafitinib
FDA (1) FGFR3 p.Y373C Bladder Urothelial Carcinoma Erdafitinib
FDA (1) FGFR3::TACC3 Bladder Urothelial Carcinoma Erdafitinib