强生Akeega®双效片获CHMP积极意见 用于BRCA突变转移性激素敏感性前列腺癌治疗

美股速递
Jan 30

强生公司宣布,其创新药物Akeega®(尼拉帕利和醋酸阿比特龙双效片剂)获得欧洲药品管理局人用药品委员会(CHMP)的积极审评意见。该药物拟用于治疗携带BRCA1/2基因突变的转移性激素敏感性前列腺癌(mHSPC)患者。

此次CHMP的积极意见基于III期临床研究数据,表明Akeega®作为首款针对该适应症的双效片剂,能显著延缓疾病进展。若获得欧盟最终批准,这款每日一次的口服疗法将为特定前列腺癌患者提供新的治疗选择。

目前欧洲委员会将进行最终审批决定,预计结果将在今年下半年公布。该决定将影响欧盟27个成员国及冰岛、挪威等欧洲经济区国家的临床应用准入。

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