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诺华公司色瑞替尼胶囊治疗ALK酪氨酸激酶受体阳性(ALK+)转移性非小细胞肺癌(NSCLC)患者(克唑替尼治疗时进展或无法耐受)获得了美国食品药品监督管理局(FDA)批准。对163例克唑替尼治疗时疾病进展或不能耐受其治疗的转移性ALK+NSCLC患者实施的关键性研究中,复治患者的总缓解率是54.6%,缓解持续时间中位数是7.4个月。发生率至少为25%的不良事件包括腹泻、恶心、转氨酶升高、呕吐、腹
Novartis Cer- tinib capsules have been approved by the U.S. Food and Drug Administration for the treatment of ALK tyrosine kinase receptor-positive (ALK +) metastatic non-small cell lung cancer (NSCLC) patients (progression or intolerability during crizotinib treatment) (FDA) approval. In a pivotal study of 163 patients with metastatic ALK + NSCLC who progressed or were refractory to treatment with crizotinib, the overall response rate for retreatment patients was 54.6% and the median duration of remission was 7.4 Months. Adverse events occurring at least 25% include diarrhea, nausea, elevated transaminases, vomiting, abdominal