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FDA授予辉瑞公司的下一代间变性淋巴瘤激酶(ALK)/酪氨酸激酶(ROS)1抑制剂劳拉替尼(lorlatinib)治疗ALK阳性转移性非小细胞肺癌的突破性治疗药资格。突破性治疗药资格由劳拉替尼Ⅰ/Ⅱ临床试验的疗效和安全性资料支持,包括先前用过≥1种ALK抑制剂治疗的患者。此外,Ⅲ期临床CROWN试验开始入选患者,此为开放、随机、两组别研究,比较该药与克唑替尼(crizotinib)一线治疗ALK阳性转移性非小细胞肺
FDA grants Pfizer the next generation of anaplastic lymphoma kinase (ALK) / tyrosine kinase (ROS) 1 inhibitor lorlatinib for the breakthrough treatment of ALK-positive metastatic non-small cell lung cancer. Breakthrough Therapeutic eligibility is supported by efficacy and safety data for the Lauritinib clinical trials, including those previously treated with ≥1 ALK inhibitor. In addition, the Phase III clinical trial of CROWN was initially enrolled in this study as an open, randomized, two-arm study comparing first-line treatment of ALK-positive metastatic non-small cell lung cancer with crizotinib