Balversa (erdafitinib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- erdafitinib
- Status
- Authorised
- Therapeutic area
- Urologic Neoplasms
- CHMP opinion
- Thu 27 Jun 2024
- EU approval
- Thu 22 Aug 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006050
- ATC
- L01EN01
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.