Cancer Discov. 2017 Jul;7(7):656. doi: 10.1158/2159-8290.CD-NB2017-078. Epub 2017 Jun 5.
The PD-1 inhibitor pembrolizumab received accelerated approval for adult and pediatric patients with solid tumors that are mismatch repair-deficient or microsatellite instability-high. This is the first time the FDA has greenlighted a drug based not on tumor type, but on a common biomarker.
PD-1 抑制剂帕博利珠单抗获得加速批准,用于错配修复缺陷或微卫星高度不稳定的成人和儿科实体瘤患者。这是 FDA 首次批准一种药物不是基于肿瘤类型,而是基于一种常见的生物标志物。