Balversa (erdafitinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Janssen-Cilag International N.V. Balversa (erdafitinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf. Revised August 2024. Accessed October 19, 2024.

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Regulatory approvals

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

Indication Statements
Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting. 8

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
EMA (1) FGFR3 p.R248C Bladder Urothelial Carcinoma Erdafitinib
EMA (1) FGFR3 p.S249C Bladder Urothelial Carcinoma Erdafitinib
EMA (1) FGFR3 p.G370C Bladder Urothelial Carcinoma Erdafitinib
EMA (1) FGFR3 p.Y373C Bladder Urothelial Carcinoma Erdafitinib
EMA (1) FGFR3::TACC3 Bladder Urothelial Carcinoma Erdafitinib
EMA (1) FGFR2::BICC1 Bladder Urothelial Carcinoma Erdafitinib
EMA (1) FGFR2::CASP7 Bladder Urothelial Carcinoma Erdafitinib
EMA (1) FGFR3::BAIAP2L1 Bladder Urothelial Carcinoma Erdafitinib