2017年5月23日,据官网消息,美国FDA批准了默沙东公司的“明星”PD-1抗体Keytruda用于治疗携带一种特定基因特征的任何一种实体瘤。这是美国FDA批准的首款不依据肿瘤来源,而是依据生物标志物进行区分的抗肿瘤疗法。具体来说,Keytruda被批准用于治疗携带微卫星不稳定性高(microsatellite instability-high,MSI-H)或错配修复缺陷(mismatch repair deficient,d MMR)的成人和儿童实体瘤患者。这些患者的肿瘤不可切除或 May 23, 2017 According to official website, the U.S. FDA approved Merck’s “Star” PD-1 antibody Keytruda to treat any solid tumor that carries a particular gene signature. This is the first anti-cancer therapy approved by the U.S. FDA that is based on a combination of biomarkers, not on the basis of the tumor. In particular, Keytruda is approved for the treatment of solid tumors in adults and children carrying microsatellite instability-high (MSI-H) or mismatch repair deficient (d MMR). The tumors in these patients are unresectable or