Balversa is used to treat urothelial cancer (cancer of the bladder and urinary system) in adults. It is used on its own when the cancer is unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body). Balversa is given to patients whose tumours have changes in the fibroblast growth factor receptor 3 (FGFR3) gene and have worsened after treatment known as immunotherapy. Balversa contains the active substance erdafitinib.
Therapeutic Indication
### Therapeutic indication 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 (see section 5.1).
Therapeutic Area (MeSH)
ATC Code
L01EN01
ATC Item
erdafitinib
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Erdafitinib | N/A | 厄达替尼 |
EMA Name
Balversa
Medicine Name
Balversa
Aliases
N/ANo risk management plan link.