金吾财讯 | 强生（JNJ）周四公告，其联合Halozyme（HALO）共同开发的抗癌药物Rybrevant Faspro新适应症申请获得美国FDA优先审查资格，拟用于复发性或转移性头颈部鳞状细胞癌。本次补充生物制品许可申请依托关键性1b/2期OrigAMI-4临床试验数据支撑，试验结果显示，42%的头颈部鳞癌患者接受治疗后产生应答，超三分之一受试者实现肿瘤完全缓解。凭借优先审评通道，FDA审查周期将缩短至6个月，常规审批时长为10个月，有望加速这款双靶点皮下制剂落地。Rybrevant Faspro靶向EGFR与MET通路，当前已获批用于肺癌治疗。若头颈癌适应症顺利获批，将进一步拓宽产品收入空间，同时利好合作方Halozyme。市场持续等待FDA最终审批结论，跟踪该药物在实体瘤领域持续拓展潜力。
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