百济神州(06160.HK)：EMA受理泽布替尼治疗华氏巨球蛋白血症患者上市许可申请
格隆汇 6 月 26日丨百济神州(06160.HK)发布公告，公司是一家处于商业阶段的生物科技公司，专注于用于癌症治疗的创新型分子靶向和肿瘤免疫药物的开发和商业化。公司于2020年6月18日宣布欧洲药品管理局(EMA)已确认受理百悦泽® (泽布替尼)的上市许可申请(MAA)，适用于既往接受过至少一项疗法的华氏巨球蛋白血症 (WM)患者或作为不适合化学免疫疗法WM患者的一线治疗方案。
百济神州血液学首席医学官黄蔚娟医学博士表示：“这是我们向EMA递交的首项申请，也是针对WM适应症的首项药品注册申请，在百悦泽®的开发历程中具有重要意义。在公司开展的头对头ASPEN临床试验中，百悦泽®对比第一代BTK抑制剂伊布替尼，在WM患者中证实有效并在安全性及耐受性上产生了具有临床意义的改善。在中国和美国，百悦泽®已在其他适应症中获批，我们也很高兴能够继续推动这项广泛的全球开发项目以帮助B细胞淋巴瘤患者。”黄蔚娟医学博士补充道：“WM通常出现在年龄较大的患者中，百悦泽®对比伊布替尼在心血管疾病安全性上更有优势，我们希望这一点能够说明百悦泽®成为欧洲WM患者的首选治疗方案。”
百济神州高级副总裁、全球药政事务负责人闫小军女士评论道：“我们很高兴能够完成公司自主研发的BTK抑制剂百悦泽®的首项EMA注册申请，也期待在这项针对华氏巨球蛋白血症的上市申请审评过程中与EMA进行沟通交流。我们要感谢参与临床试验的众多患者和研究人员，以及致力于将这款潜在的新一代治疗方案带给广大患者的百济神州团队。”
该项MAA中的临床数据包括在2020年美国临床肿瘤学会(ASCO)线上会议以及第25届欧洲血液学协会(EHA)线上年会中公布的用于评估泽布替尼对比伊布替尼用于治疗复发╱难治性(R/R)或初治(TN)WM患者的随机、开放性、多中心的 ASPEN 3期临床试验(NCT03053440)。MAA的安全性数据来自在6项临床试验中接受百悦泽®治疗的779例B细胞恶性肿瘤患者。
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