CHMP positive for Balversa (erdafitinib) to treat urothelial carcinoma (bladder cancer)harbouring susceptible FGFR3 genetic alterations-Janssen-Cilag (J&J)
Balversa will be available as 3 mg, 4 mg and 5 mg film-coated tablets. The active substance of Balversa is erdafitinib, an antineoplastic, protein kinase inhibitor (ATC code: L01EN01) that inhibits the fibroblast growth factor receptor (FGFR) tyrosine kinases. Deregulation of FGFR3 signalling has been implicated in the pathogenesis of urothelial cancer and FGFR inhibition has shown antitumour activity in FGFR-expressing cells.
The benefits of Balversa are its superiority in terms of overall survival and progression free survival compared to chemotherapy, as seen in a phase III, randomised controlled open-label study in patients with advanced urothelial cancer with FGFR gene aberrations. The most common side effects are hyperphosphataemia, diarrhoea and stomatitis.
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