智通财经APP获悉，1月17日，阿斯利康(AZN.US)宣布BTK抑制剂Calquence(阿可替尼)获FDA批准新适应症，用于联合苯达莫司汀和利妥昔单抗治疗既往未经治疗且不适合自体造血干细胞移植的套细胞淋巴瘤(MCL)成人患者。该药物是首个获准用于一线治疗MCL的BTK抑制剂。
FDA此次批准主要是基于III期ECHO研究的积极结果。该研究是一项多中心、随机、双盲、安慰剂对照临床试验(n=635)，评估了阿可替尼联合标准治疗(SOC，即苯达莫司汀+利妥昔单抗)对比SOC治疗既往未经治疗的65岁或以上MCL成人患者的疗效和安全性。研究的主要终点是无进展生存期(PFS)。
结果显示，阿可替尼组MCL患者的PFS延长效果优于SOC组(66.4 vs 49.6个月，HR=0.73，P=0.0160)，数据具有统计学意义和临床意义。此外，在该研究中还观察到阿可替尼组MCL患者的总生存期(OS)呈延长的积极趋势(HR=0.86，P=0.27)。
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