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遠大醫藥(00512.HK)聯營公司產品完成首例患者給藥
阿思達克 05-10 08:45
遠大醫藥(00512.HK)公布,聯營公司Sirtex的核心產品SIR-Spheres釔[90Y]樹脂微球,繼獲美國食品藥品管理局(FDA)批准開展原發性肝癌臨床試驗後,已於近期順利完成首例患者給藥。

公司表示,是次SIR-Spheres釔[90Y]樹脂微球在美國開展的針對原發性肝癌患者的臨床研究DOORwaY90,旨在評估SIR-Spheres釔[90Y]樹脂微球作為不能切除或不能手術的原發性肝癌患者一線治療的安全性和有效性,用以在美國申請原發性肝癌適應症獲批。研究將在以MD安德森癌症中心為首的15個腫瘤研究中心開展,入組100名患者開展開放式單臂研究,首要臨床終點將考察整體回應率及回應持續時間。

DOORwaY90將會是美國首個使用個性化治療劑量並進行治療後劑量驗證以評估治療終點的註冊性臨床研究,將會進一步為SIRSpheres釔[90Y]樹脂微球產品在原發性肝癌患者的應用提供高品質的支持數據,惠及更多原發性肝癌患者。

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