Balversa
What Balversa is used for
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).
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Balversa
- Active substance
- erdafitinib
- Disease area
- Urologic Neoplasms
- Medicine group
- Antineoplastic agents
- ATC code
- L01EN01
- Authorised in the EU since
- 2024
Official information
In the USA
Same active substance: Balversa
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Balversa used for?
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).
What is the active substance in Balversa?
Balversa contains erdafitinib.
Who makes Balversa?
The EU marketing authorisation holder is .
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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