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远大医药(00512.HK)联营公司产品完成首例患者给药
阿思达克 05-10 08:45
远大医药(00512.HK)公布,联营公司Sirtex的核心产品SIR-Spheres钇[90Y]树脂微球,继获美国食品药品管理局(FDA)批准开展原发性肝癌临床试验後,已於近期顺利完成首例患者给药。

公司表示,是次SIR-Spheres钇[90Y]树脂微球在美国开展的针对原发性肝癌患者的临床研究DOORwaY90,旨在评估SIR-Spheres钇[90Y]树脂微球作为不能切除或不能手术的原发性肝癌患者一线治疗的安全性和有效性,用以在美国申请原发性肝癌适应症获批。研究将在以MD安德森癌症中心为首的15个肿瘤研究中心开展,入组100名患者开展开放式单臂研究,首要临床终点将考察整体回应率及回应持续时间。

DOORwaY90将会是美国首个使用个性化治疗剂量并进行治疗後剂量验证以评估治疗终点的注册性临床研究,将会进一步为SIRSpheres钇[90Y]树脂微球产品在原发性肝癌患者的应用提供高品质的支持数据,惠及更多原发性肝癌患者。

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