CHMP adopts positive opinion for BALVERSA® (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations...
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
The CHMP's recommendation is based on results from Cohort 1 of the Phase 3 THOR study, which showed a 36 percent reduction in the risk of death with erdafitinib versus chemotherapy BEERSE, Belgium , June 28, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for BALVERSA ® (erdafitinib) as a once-daily oral monotherapy 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. Erdafitinib is the first targeted therapy to receive a positive CHMP recommendation in this patient population. “FGFR alterations are important oncogenic drivers in urothelial carcinoma an
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