avelumab

1 INDICATIONS AND USAGE BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. ( 1.1 , 14.1 ) Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. ( 1.2 , 14.2 ) Patients with locally advanced or metastatic UC who: Have disease progression during or following platinum-containing chemotherapy. ( 1.2 , 14.2 ) Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.2 , 14.2 ) Renal Cell Carcinoma (RCC) First-line treatment, in combination with axitinib, of patients with advanced RCC. ( 1.3 , 14.3 ) 1.1 Metastatic Merkel Cell Carcinoma BAVENCIO (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) [see Clinical Studies (14.1) ] . 1.2 Locally Advanced or Metastatic Urothelial Carcinoma First-Line Maintenance Treatment of Urothelial Carcinoma BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy [see Clinical Studies (14.2) ] . Previously-treated Urothelial Carcinoma BAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy [see Clinical Studies (14.2) ]. 1.3 Advanced Renal Cell Carcinoma BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC) [see Clinical Studies (14.3) ] .