今天FDA提前四个月批准了罗氏旗下基因泰克的PD-L1抗体atezolizumab(商品名Tecentriq),作为二线药物用于治疗一种叫做urothelial carcinoma的最常见晚期膀胱癌。同时FDA也批准了Ventana的PD-L1伴随诊断试剂SP142。在一个310患者参与的单臂临床试验中,15%患者对Tecentriq应答。其中PD-L1表达阳性患者应答率为26%,PD-L1阴性患者应答率为10%。 FDA today approved Roche’s Genentech PD-L1 antibody atezolizumab (trade name Tecentriq) four months in advance as a second-line drug for the treatment of one of the most common advanced bladder cancers called urothelial carcinoma. FDA also approved Ventana’s PD-L1 Concomitant Diagnostic Reagent SP142. In a single arm clinical trial involving 310 patients, 15% of patients responded to Tecentriq. Among them, the response rate of PD-L1 positive patients was 26% and that of PD-L1 negative patients was 10%.