和黃醫藥(00013.HK)治療轉移性結直腸癌藥物研究完成患者入組
和黃醫藥(00013.HK)公布,早前在美國、歐洲、日本和澳洲啟動的(口夫)(口奎)替尼治療轉移性結直腸癌患者的全球III期註冊研究FRESCO-2已順利完成患者入組。患者入組目標已於上周四(2日)達成。
FRESCO-2是一項在轉移性結直腸癌患者中開展的隨機、雙盲、安慰劑對照的多中心臨床試驗。該研究的主要終點是總生存期(OS)。該項大型III期研究於14個國家的超過150個研究中心開展患者招募。
該項研究的頂線結果預計將於2022年下半年,當事件驅動的主要終點-總生存期(OS)數據成熟時公布。若取得積極結果,公司將啟動計劃向美國食品藥監局(FDA)、歐洲藥品管理局(EMA)和日本醫藥品醫療機器綜合機構(PMDA)遞交(口夫)(口奎)替尼的上市許可申請。FDA已於去年6月授予(口夫)(口奎)替尼快速通道資格,開發用於治療轉移性結直腸癌患者。
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