Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized erdafitinib 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. This indication is based on BLC3001 Study Cohort 1, a Phase 3, randomised, open-label, multicentre study, where eligible patients were required to have at least one of the following FGFR fusions: FGFR2::BICC1, FGFR2::CASP7, FGFR3::TACC3, FGFR3::BAIAP2L1; or 1 of the following FGFR3 gene mutations: R248C, S249C, G370C, Y373C.
This is written in the approval document as:
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.
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | FGFR2::BICC1 | Bladder Urothelial Carcinoma | Erdafitinib | |
| Sensitivity (+) | FGFR2::CASP7 | Bladder Urothelial Carcinoma | Erdafitinib | |
| Sensitivity (+) | FGFR3::TACC3 | Bladder Urothelial Carcinoma | Erdafitinib | |
| Sensitivity (+) | FGFR3::BAIAP2L1 | Bladder Urothelial Carcinoma | Erdafitinib | |
| 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 |