百济神州(06160.HK)宣布FDA已受理百悦泽®针对边缘区淋巴瘤的新适应症上市申请并授予优先审评
格隆汇5月20日丨百济神州(06160.HK)于2021年5月19日(美国东部时间)宣布,美国食品药品监督管理局(FDA)已受理百悦泽®(泽布替尼)用于治疗先前接受过至少一项CD20导向疗法的成年边缘区淋巴瘤(MZL)患者的新适应症上市申请(sNDA)并授予其优先审评资格。处方药申报者付费法案(PDUFA)日期为2021年9月19日。
百济神州血液学首席医学官黄蔚娟医学博士表示:“这是公司针对边缘区淋巴瘤提交的首项药政申请。在美国,每年有2,000多人被诊断出患有边缘区淋巴瘤,但却没有统一的标准疗法。百悦泽®在针对边缘区淋巴瘤的临床试验中显示出鼓舞人心的有效性和耐受性,为这些患者提供了一款潜在的全新治疗选择。我们会在接下来的几个月中不断与FDA进行沟通,继续推进针对百悦泽®这款潜在同类最佳BTK抑制剂的广泛的全球临床开发项目。”
该项sNDA的临床数据来自一项百悦泽®用于治疗复发或难治性MZL患者的单臂、开放性、多中心2期MAGNOLIA临床试验(NCT03846427)结果(于2020年12月在美国血液学年会中公布),以及一项百悦泽®针对B细胞恶性肿瘤的全球1/2期临床试验(NCT02343120)的支援性数据。同时,参与7项百悦泽®临床试验的847例患者的汇总安全性资料也被包含在该项sNDA中。
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