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The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend approval of the combination of avelumab and axitinib for the frontline treatment of adult patients with advanced renal cell carcinoma.

The FDA has granted a priority review designation to a biologics license application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.