Posted by Michael Wonder on 11 Nov 2024
MHRA grants marketing authorisation for Balversa (erdafitinib) as monotherapy for the treatment of adults 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
6 November 2024 - Erdafitinib is the first and only bladder cancer therapy that targets FGFR3 alterations and has been shown to increase overall survival from 7.8 months to 12.1 months (with a 95% confidence interval) compared to chemotherapy.
Johnson & Johnson has announced that the MHRA has granted marketing authorisation for Balversa (erdafitinib) as a monotherapy for the treatment of adults with unresectable or metastatic urothelial carcinoma, the most common form of bladder cancer.
