吉利德科学:欧盟批准Trodelvy联合Keytruda用于一线PD-L1阳性转移性三阴性乳腺癌

美股速递
Yesterday

吉利德科学公司宣布,欧盟已正式授予其抗体药物偶联物Trodelvy与默沙东的Keytruda联合用药方案的上市许可。这一批准针对的是既往未经治疗的PD-L1阳性转移性三阴性乳腺癌患者群体。此项授权标志着该联合疗法在欧盟地区的临床可及性迈出关键一步,为这类侵袭性强、治疗选择有限的乳腺癌亚型患者提供了新的一线治疗选项。值得注意的是,Trodelvy作为一款靶向Trop-2的抗体药物偶联物,其与免疫检查点抑制剂Keytruda的组合策略,旨在通过协同机制增强抗肿瘤免疫应答,从而改善患者预后。此次欧盟层面的积极决定,是基于一项关键的III期临床试验数据,该研究证实了该联合方案在无进展生存期和总生存期方面均显示出具有统计学意义的显著改善。此举也进一步巩固了吉利德在肿瘤学领域的布局,尤其是在精准治疗和联合疗法探索方面的领先地位。

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