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劳拉替尼于2018年11月02日获FDA批准上市，用于治疗接受克唑替尼和至少一种其它ALK抑制剂治疗之后疾病发生恶化，或接受阿来替尼（alectinib）或色瑞替尼（ceritinib）作为第一个ALK抑制剂治疗但疾病恶化的ALK阳性转移性非小细胞肺癌（NSCLC）患者。

Loratinib was approved by the FDA on November 02, 2018 for the treatment of disease progression following treatment with crizotinib and at least one other ALK inhibitor. Or patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who were treated with alectinib or ceritinib as the first ALK inhibitor but whose disease worsened.

劳拉替尼是一种第三代ALK抑制剂，属于ALK/ROS1双靶点抑制剂。虽然许多ALK阳性转移性NSCLC患者最初对TKI治疗有反应，然而耐药是不可避免的问题，劳拉替尼可有效对抗各类ALK继发的耐药基因突变，并且有较强的中枢神经系统渗透性，保持脑组织中较高的血药浓度。

2021年3月3日，FDA批准了辉瑞公司研发生产的三代ALK抑制剂劳拉替尼（lorlatinib）一线治疗ALK阳性转移性NSCLC患者。 该批准是基于III期的CROWN临床研究结果，显示与克唑替尼相比，劳拉替尼一线治疗ALK阳性的NSCLC患者疾病进展或死亡风险降低了72%（HR0.28，95%CI,0.19-0.41；p<0.0001）。

On March 3, 2021, the U.S. Food and Drug Administration (FDA) approved Pfizer inc. 's third-generation ALK inhibitor lorlatinib for the first-line treatment of patients with alK-positive metastatic NSCLC. This approval is based on the results of a Phase III CROWN clinical trial that showed a 72% reduction in the risk of disease progression or death in alK-positive NSCLC patients treated with first-line treatment of loratinib compared with crizotinib (HR0.28, 95%CI,0.19-0.41; P < 0.0001).