NEW BRUNSWICK (dpa-AFX) - 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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