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雲頂新耀(01952.HK)旗下治療轉移性乳腺癌藥物臨床試驗申請獲批
阿思達克 11-02 08:25
雲頂新耀(01952.HK)公布,中國國家藥品監督管理局通過了Trodelvy(sacituzumab govitecan)用於治療至少兩種既往化療方案治療失敗的激素受體陽性/人表皮生長因數受體2陰性(「HR+╱HER2-」)轉移性乳腺癌(「mBC」)的臨床試驗申請(「CTA」)。

隨著臨床試驗申請的獲批,公司計劃啟動3期註冊臨床試驗EVER-132-002,這項試驗旨在評估和比較sacituzumab govitecan與醫生選擇的治療(TPC)在接受過至少2種但不超過4種既往化療方案的HR/HER2-轉移性乳腺癌的亞洲患者的有效性和安全性。該試驗將在內地、台灣及韓國招募大約330名HR+/HER2-轉移性乳腺癌患者。

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