Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to erdafitinib 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. Erdafitinib's product label states for patients to be selected for therapy based on an FDA-approved companion diagnostic for erdafitinib. Furthermore, erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	FGFR3 p.R248C	Bladder Urothelial Carcinoma	Erdafitinib
Sensitivity (+)	FGFR3 p.S249C	Bladder Urothelial Carcinoma	Erdafitinib
Sensitivity (+)	FGFR3 p.G370C	Bladder Urothelial Carcinoma	Erdafitinib
Sensitivity (+)	FGFR3 p.Y373C	Bladder Urothelial Carcinoma	Erdafitinib
Sensitivity (+)	FGFR3::TACC3	Bladder Urothelial Carcinoma	Erdafitinib