01:16 PM EDT, 08/23/2024 (MT Newswires) -- Johnson & Johnson-backed (JNJ) Janssen-Cilag International said Friday that the European Commission approved Balversa as a once-daily oral monotherapy for adults with unresectable or metastatic urothelial carcinoma.

The approval came after the company announced results from the phase 3 study, evaluating the efficacy and safety of Balversa, or erdafitinib, showing a 36% reduction in risk of death compared to chemotherapy in individuals with advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor gene changes.

The shares of Johnson & Johnson ( JNJ ) were up 0.1% in recent trading.

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