Regulatory approval
Published by the Health Canada.
Health Canada approved erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC) harboring susceptible FGFR3 genetic alterations, who have experienced disease progression during or after at least one line of prior therapy, including within 12 months of neoadjuvant or adjuvant therapy.
This is written in the approval document as:
BALVERSA (erdafitinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, who have disease progression during or following at least one line of prior therapy including within 12 months of neoadjuvant or adjuvant therapy.
Citation
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 |