CHMP okays first therapy targeting FGFR3 alterations in bladder cancer
Drug Discovery World
JULY 2, 2024
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Janssen-Cilag’s Balversa (erdafitinib). It is recommended as a monotherapy to treat adult patients with unresectable or metastatic urothelial carcinoma, 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.
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