Janssen-Cilag International NV, a Johnson & Johnson (JNJ) company, Friday said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Balversa for the treatment of patients with unresectable or metastatic urothelial carcinoma (UC).
The positive CHMP opinion is supported by data from Cohort 1 of the Phase 3 THOR study, which showed a 36 percent reduction in the risk of death with Balversa versus chemotherapy.
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