智通财经APP获悉,美国食品药品管理局(FDA)已授予礼来(LLY.US)旗下候选药物Olomorasib用于治疗KRAS G12C突变型非小细胞肺癌(NSCLC)的孤儿药资格。据悉,该药物目前正处于用于上述适应症的三期临床试验阶段。其正在接受评估,作为一线治疗方案,用于KRAS G12C突变型晚期非小细胞肺癌患者,与Keytruda(帕博利珠单抗)联合使用,可选择是否同时联合化疗。
去年8月,礼来在由美国临床肿瘤学会(ASCO)主办的2024年美国临床肿瘤学会突破峰会上公布的数据显示,Olomorasib(50或100mg BID)联合Keytruda在KRAS G12C突变晚期非小细胞肺癌患者中显示出良好的安全性和抗肿瘤活性,支持一线非小细胞肺癌的进一步发展。
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